510(k) Report

510(k) · Cleared

Cleared

Vydence Family of Lasers

K252753510(k) TraditionalCleared Jan 24, 2026148-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vydence Medical Industria E Commercio Ltda · GEX Powered Laser Surgical Instrument

Cleared on Jan 24, 2026 as substantially equivalent to K190007 (Vydence Medical Industria E Comercio Ltda, 2019) and 2 other predicates after a 148-day review. Its family tree reaches back 27 generations to 1995.

Decided
Jan 24, 2026
Review
148 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
3

Its longest line of descent runs back 27 generations to K943450 (1995). 316 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2022: 1 other ancestor2019: 2 other ancestors2017: 2 other ancestors2015: 3 other ancestors2014: 4 other ancestors2016: 2 other ancestors2004: 17 other ancestors2002: 35 other ancestors1999: 11 other ancestors2012: 3 other ancestors2011: 2 other ancestors2008: 4 other ancestors2006: 7 other ancestors2005: 10 other ancestors1997: 24 other ancestors2013: 1 other ancestor2009: 2 other ancestors2003: 24 other ancestors2001: 26 other ancestors2000: 26 other ancestors1998: 15 other ancestors1996: 17 other ancestors1995: 12 other ancestors1990: 3 other ancestors1988: 2 other ancestors2007: 2 other ancestors1994: 12 other ancestors1993: 8 other ancestors1991: 4 other ancestors1989: 2 other ancestors1992: 3 other ancestors1982: 1 other ancestor1980: 1 other ancestor1985: 1 other ancestorK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K000944 · Thermage Thermacool System · Thermage, Inc. · 2000×2: 2 generations cleared close together, K013034 (2001), K013639 (2002) ×2: 2 generations cleared close together, K021402 (2002), K030142 (2003) K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K051214 · Aluma Skin Renewal System · Lumenis, Inc. · 2005K060448 · Lumenis One Family of Systems; Lumenis One. · Lumenis, Ltd. · 2006K072564 · Alma Lasers Harmony XL Multi-Application Platform · Alma Lasers, Ltd. · 2008K083899 · Revlite Q-Switched ND:Yag Laser System · Hoya Conbio, Inc. · 2009K103118 · Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor · Hoya Photonics, Inc. · 2010 · recalledK121346 · Picosure Workstation · Cynosure, Inc. · 2012×3: 3 generations cleared close together, K133364 (2014), K140719 (2014), K143105 (2015) ×2: 2 generations cleared close together, K153527 (2016), K160607 (2016) ×2: 2 generations cleared close together, K162454 (2017), K170597 (2017) K191685 · PicoWay Laser System · Candela Corporation · 2019K242534 · HandPICO Fractional Laser Handpiece Tip · Vydence Medical · 202419801990200020102020
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor3 generations back: 1 other ancestor4 generations back: 3 other ancestors5 generations back: 6 other ancestors6 generations back: 5 other ancestors7 generations back: 10 other ancestors8 generations back: 40 other ancestors9 generations back: 84 other ancestors10 generations back: 74 other ancestors11 generations back: 31 other ancestors12 generations back: 21 other ancestors13 generations back: 10 other ancestors14 generations back: 1 other ancestor K242534 · HandPICO Fractional Laser Handpiece Tip · Vydence Medical · 2024K191685 · PicoWay Laser System · Candela Corporation · 2019K170597 · PicoWay Laser System · Syneron Candela Corporation · 2017K162454 · PicoWay Laser System · Syneron Candela Corporation · 2017K160607 · PicoWay Laser System · Syneron Candela Corporation · 2016K153527 · PicoWay Laser System · Syneron Candela Corporation · 2016K143105 · Picosure Workstation · Cynosure, Inc. · 2015K140719 · Picosure Workstation · Cynosure, Inc. · 2014K133364 · Picosure Workstation · Cynosure, Inc. · 2014K121346 · Picosure Workstation · Cynosure, Inc. · 2012K103118 · Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor · Hoya Photonics, Inc. · 2010 · recalledK083899 · Revlite Q-Switched ND:Yag Laser System · Hoya Conbio, Inc. · 2009K072564 · Alma Lasers Harmony XL Multi-Application Platform · Alma Lasers, Ltd. · 2008K060448 · Lumenis One Family of Systems; Lumenis One. · Lumenis, Ltd. · 2006K051214 · Aluma Skin Renewal System · Lumenis, Inc. · 2005K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K030142 · Thermacool TC System · Thermage, Inc. · 2003K021402 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013639 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013034 · Modification to: Thermacool Iia · Thermage, Inc. · 2001K000944 · Thermage Thermacool System · Thermage, Inc. · 2000K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−25−20−15−10−50
  1. Root · 27 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 23 generations between
  3. 3 generations backK170597 PicoWay Laser SystemSyneron Candela Corporation · 2017
  4. 2 generations backK191685 PicoWay Laser SystemCandela Corporation · 2019
  5. 1 generation backK242534 HandPICO Fractional Laser Handpiece TipVydence Medical · 2024
  6. This deviceK252753 Vydence Family of LasersVydence Medical Industria E Commercio Ltda · 2026
Show all 27 generations
  1. Root · 27 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 26 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 25 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 24 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 23 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 22 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 21 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. 20 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  9. 19 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  10. 18 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  11. 17 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
  12. 16 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
  13. 15 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
  14. 14 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
  15. 13 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
  16. 12 generations backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
  17. 11 generations backK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
  18. 10 generations backK121346 Picosure WorkstationCynosure, Inc. · 2012
  19. 9 generations backK133364 Picosure WorkstationCynosure, Inc. · 2014
  20. 8 generations backK140719 Picosure WorkstationCynosure, Inc. · 2014
  21. 7 generations backK143105 Picosure WorkstationCynosure, Inc. · 2015
  22. 6 generations backK153527 PicoWay Laser SystemSyneron Candela Corporation · 2016
  23. 5 generations backK160607 PicoWay Laser SystemSyneron Candela Corporation · 2016
  24. 4 generations backK162454 PicoWay Laser SystemSyneron Candela Corporation · 2017
  25. 3 generations backK170597 PicoWay Laser SystemSyneron Candela Corporation · 2017
  26. 2 generations backK191685 PicoWay Laser SystemCandela Corporation · 2019
  27. 1 generation backK242534 HandPICO Fractional Laser Handpiece TipVydence Medical · 2024
  28. This deviceK252753 Vydence Family of LasersVydence Medical Industria E Commercio Ltda · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−27K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−26K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−25K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−24K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−23K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−22K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−21K000944Thermage Thermacool SystemThermage, Inc.2000—
−20K013034Modification to: Thermacool IiaThermage, Inc.2001—
−19K013639Thermage Thermacool TC SystemThermage, Inc.2002—
−18K021402Thermage Thermacool TC SystemThermage, Inc.2002—
−17K030142Thermacool TC SystemThermage, Inc.2003—
−16K031671Polaris WRSyneron Medical, Ltd.2003—
−15K051214Aluma Skin Renewal SystemLumenis, Inc.2005—
−14K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006—
−13K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008—
−12K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009—
−11K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.20101
−10K121346Picosure WorkstationCynosure, Inc.2012—
−9K133364Picosure WorkstationCynosure, Inc.2014—
−8K140719Picosure WorkstationCynosure, Inc.2014—
−7K143105Picosure WorkstationCynosure, Inc.2015—
−6K153527PicoWay Laser SystemSyneron Candela Corporation2016—
−5K160607PicoWay Laser SystemSyneron Candela Corporation2016—
−4K162454PicoWay Laser SystemSyneron Candela Corporation2017—
−3K170597PicoWay Laser SystemSyneron Candela Corporation2017—
−2K191685PicoWay Laser SystemCandela Corporation2019—
−1K242534HandPICO Fractional Laser Handpiece TipVydence Medical2024—
0 (this device)K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198210
198510
198820
198920
199030
199140
199230
199380
1994120
1995120
1996170
1997240
1998150
1999110
2000260
2001260
2002350
2003240
2004170
2005100
200670
200720
200840
200920
201120
201230
201310
201440
201530
201620
201720
201920
202210
FIG. 1 — Lineage of K252753, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEX device

  1. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K190007Vydence Laser Family
Summary page 10
…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code I K190007 Vydence Family of Lasers GEX,PDZ, Ob IK242534…
Vydence Medical Industria E Comercio Ltda2019—
*K242534HandPICO Fractional Laser Handpiece Tip
Summary page 10
…Product Code I K190007 Vydence Family of Lasers GEX,PDZ, Ob IK242534 I HandPico Fractional IGEX I K220041…
Vydence Medical2024—
*K220041HandPICO
Summary page 10
…GEX,PDZ, Ob IK242534 I HandPico Fractional IGEX I K220041 I HandPico IGEX Device Description…
Vydence Medical Industria E Comercio Ltda2022—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 31 years and passes through 13 companies; a new generation was cleared every 10 months on median.
  • 15 of the 316 ancestors have a recall of any class.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · GEX

83in 2025

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

What is it indicated for?

IPL 390nm-51Onm Filter * The treatment of inflammatory acne (acne vulgaris); * The treatment of leukoderma, including vitiligo (acquired leukoderma). IPL 400nm-1200nm Filter * The treatment of moderate inflammatory acne vulgaris; * The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles); * The treatment of benign cutaneous lesions including warts, scars and striae; * The treatment of…

Read the full statement (2,377 words)

IPL 390nm-51Onm Filter

* The treatment of inflammatory acne (acne vulgaris);

* The treatment of leukoderma, including vitiligo (acquired leukoderma).

IPL 400nm-1200nm Filter

* The treatment of moderate inflammatory acne vulgaris;

* The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma,

and ephelides (freckles);

* The treatment of benign cutaneous lesions including warts, scars and striae;

* The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial,

truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas,

Poikiloderma of Civatte, leg veins and venous malformations.

* Use on all skin types (Fitzpatrick 1-VI).

IPL 515-1200nm Filter

* The treatment of moderate inflammatory acne (acne vulgaris).

*The treatment of tattoos and benign pigmented epidermal and benign cutaneous lesions including warts,

scars, striae, dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, melasma, an

cafe-au-lait macules.

*The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial,

truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas,

poikiloderma of Civatte, leg veins and venous malformations.

*The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction

in hair growth is defined as the long-term , stable reduction in the number of hairs regrowing when

measured at 6,9 and 12 months after the completion of a treatment regime.

* Use on all skin types (Fitzpatrick I-V).

IPL 540nm-1200nm Filter

* Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides

(freckles),

* Lentigines, nevi, and cafe-au-lait macules;

*The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial,

truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas,

poikiloderma of Civatte, leg veins and venous malformations.

* The treatment of benign cutaneous lesions including warts, scars and striae.

*The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction

in hair growth is defined as the long-term , stable reduction in the number of hairs regrowing when

measured at 6,9 and 12 months after the completion of a treatment regime.

* Use on all skin types (Fitzpatrick 1-VI).

IPL 540nm-1200nm Filter

* Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides

(freckles),

* lentigines, nevi, and cafe-au-lait macules;

* The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial,

truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas,

poikiloderma of Civatte, leg veins and venous malformations.

* The treatment of benign cutaneous lesions including warts, scars and striae.

*The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction

in hair growth is defined as the long-term , stable reduction in the number of hairs regrowing when

measured at 6,9 and 12 months after the completion of a treatment regime.

* Use on all skin types (Fitzpatrick 1-VI).

IPL 580nm-1200nm Filter

* The treatment of moderate inflammatory acne vulgaris.

* The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma

and ephelides (freckles).

* The treatment of face and body benign vascular and benign pigmented lesions.

* The treatment of benign cutaneous lesions, including scars and striae.

* The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial,

truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte,

leg veins and venous malformations.

* The removal of unwanted hair to effect stable long-term or permanent hair reduction. . Permanent

reduction in hair growth is defined as the long-term , stable reduction in the number of hairs regrowing when

measured at 6,9 an 12 months after the completion of a treatment regime.

* Use on all skin types (Fitzpatrick 1-VI).

IPL 640nm-1200nm Filter

* The treatment of tattoos;

* The treatment of mild to moderate inflammatory and pustular inflammatory acne vulgaris;

* The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma,

and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait;

* The treatment of benign cutaneous lesions including warts, scars and striae;

* The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial,

truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas,

poikiloderma of Civatte, leg veins and venous malformations;

* Removal of unwanted hair, for stable long term or permanent hair reduction (permanent hair reduction is

defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12

months after the completion of a treament regimen).

* Use on all skin types (Fitzpatrick 1-VI), including tanned skin.

IPL 695nm-1200nm Filter

* Removal of unwanted hair, for stable long term or permanent hair reduction (permanent hair reduction is

defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12

months after the completion of a treatment regimen).

* Use on all skin types (Fitzpatrick 1-VI), including tanned skin

Intense IR Handpiece

Intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the

tissue temperature. It's also indicated for the treatment in the temporary relief of minor muscle pain and joint

pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in

local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains

and strains, and minor muscular back pain.

1064nm Long Pulse Handpiece

* Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The

laser is indicated for all skin types, Fitzpatrick 1-VI, including tanned skin. Permanent hair reduction is

defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12

months after the completion of a treatment regime

* Treatment of pseudofolliculitis barbae (PFB)

* Benign vascular lesions such as, but not limited to treatment of: Port wine stains; Hemangiomas; Warts;

Superficial and deep telangiectasias (venulectasias); Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea;

Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas

* Benign pigmented lesions such as, but not limited to: Lentigos (age spots); Solar lentigos (sun spots);

Caf6-au-lait macules; Seborrheic keratoses; Nevi and nevus of Ota; Chloasma; verrucae, skin tags,

keratoses, the removal of black, blue, or green tattoos (significant reduction in the intensity of black and/or

blue/black tattoos), plaques

* Benign cutaneous lesions, such as, but not limited to warts, scars, striae and psoriasis

* Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from

aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

* The non-ablative treatment of facial wrinkles, such as, but not limited to: Periocular wrinkles, Perioral

wrinkles

* Laser skin resurfacing procedures for the treatment of: Acne scars, wrinkles

* Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the

scar;

1064nm Long Pulse Handpiece - Short Pulse Operation

* Intended for the coagulation and hemostasis of benign vascular lesions such as but not limited to,

rosacea/ diffuse redness, poikiloderma of civatte, scar reduction (including hypertropic and keloidscars),

and warts.

* Is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioralwrinkles.

* For use on all skin types (Fitzpatrick 1-VI), including tanned skin.

1064nm Long Pulse Handpiece - Onychomycosis

* Podiatry (i.e. ablation, vaporization, incision, excision, and coagulation of soft tissue) including

matrixectomy, radical nail excision, periungual and subungual warts, plantar warts, neuromas,

* Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton

rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.).

Acroma Handpiece

The 1064 nm wavelength is indicated for:

* Treatment of benign vascular lesions such as (but not limited to): port wine stains; hemangiomas; warts;

superficial and deep telangiectasias (venulectasias); reticular veins (0.1-4.0 mm diameter) of the leg;

rosacea; venous lakes; leg veins; spider veins; Poikiloderma of Civatte; angiomas;

* Benign cutaneous lesions, such as, but not limited to: warts; scars; striae; psoriasis;

* Benign pigmented lesions such as, but not limited to: lentigos (age spots); solar lentigos (sun spots); cafe-

au-lait macules; seborrheic keratoses; nevi and Nevus of Ota; chloasma; verrucae; skin tags; keratoses; the

removal of black, blue or green tattoos (significant reduction in the intensity of black and/or blue/black

tattoos); plaques;

* Pigmented benign lesions to reduce lesions' size for patients with lesions that would potentially benefit

from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

* The non-ablative treatment of facial wrinkles, including but not limited to: periocular wrinkles; perioral

wrinkles;

* Laser skin resurfacing procedures for the treatment of acne scars; wrinkles,

* Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the

scar.

* Indicated for use on all skin types (Fitzpatrick 1-VI), including tanned skin.

The 532 nm wavelength is indicated for:

* Incision, excision, ablation, vaporization of soft tissue;

* Tattoo removal: light blue, yellow, red; green;

* Benign vascular lesions: Hemangiomas (port wine stains/birthmarks, cavernous, cherry, spider,

hemangiomas); angiomas (cherry, spider); telangiectasias; spider nevi;

* Benign pigmented lesions: cafe-au-lait macules; lentigines (senile and solar); freckles (ephelides);

chloasma; nevi; nevus spillus; Nevus of Ota; Becker's Nevi;

* Other benign pigmented cutaneous lesions: verrucae; skin tags; keratoses; plaques

1540 GoSmooth Handpiece

* The 1540 Fractional Non-ablative Laser Handpiece is intended for use in the coagulation of soft tissue,

skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.

2940 DualMode Handpiece

Dermatology and Plastic Surgery:

* Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins;

* Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars);

Debulking benign tumors; Debulking cysts; Superficial skin lesions; Diagnostic biopsies; Decubitus ulcers;

* Podiatry

* Treatment of warts, plantar verrucae, large mosaic verrucae

* Matrixectomy

2940 DualMode Fractional

* Skin Resurfacing

1340nm ProDeep Handpiece

* Non-ablative laser handpiece is intended for use in skin resurfacing

ProDeep 6mm collimated handpiece:

* Treatment of fine lines and wrinkles, Treatment of atrophic acne scars, Treatment of mild to moderate

inflammatory acne vulgaris

755nm Fiber Delivered Handpiece

755nm Handpiece (Zye and One)

* Intended for the temporary and permanent hair reduction on all skin types (Fitzpatrick 1-VI), including

tanned skin. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at

6, 9, and 12 months after the end of a treatment regime; epidermal lesions (benign pigmented lesions) such

as solar melanosis, hyperpigmentation, melasma, and ephelides, wrinkles, treatment of benign cutaneous

lesions with vascular components including port wine stains, hemangiomas, facial and bodily telangiectasia,

erythematous rosacea, angiomas and spider angiomas, poikiloderma of Civatte and superficial venous

malformations.

1064nm Fiber Delivered Handpiece (Zye and One)

* In long pulse mode, the ZYE YAG@ applicator is designated for coagulation and hemostasis of vascular

lesions and epidermal tissue, including the treatment oftelangiectasia, superficial varicosities, angiomas

and spider angiomas, hemangiomas, rosacea, and nevi. It is also designated for non-ablative treatment of

facial wrinkles and for removal of unwanted hair, for stable long term or permanent hair reduction

(permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when

measured at 6, 9 and 12 months after the completion of a treatment regimen); for the treatment of

pseudofolliculitis barbae (PFB). Use on all skin types (Fitzpatrick 1-VI), including tanned skin.

* In the DYNAMICS® mode, for temporary increase of clear nail in patients with onychomycosis (e.g.,

dermatophytes Trichophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans,

etc.).

* In the INTENSE® mode is intended for non-invasive Laser assisted lipolysis;"

HandPICO Handpiece

532nm (pico-second):

* Removal of tattoos for Fitzpatrick skin types I-Ill with the following tattoo colors: red, yellow and orange;

* Treatment of benign pigmented lesions removal for Fitzpatrick Skin Types 1-IV.

1064nm (pico-second):

* Removal of tattoos on all skin types (Fitzpatrick skin types 1-VI) with the following tattoo colors: black,

brown, green, blue and purple.

* Treatment of benign pigmented lesions on Fitzpatrick skin types 1-IV.

532nm (nano-second):

* Treatment of benign pigmented lesions on Fitzpatrick skin types 1-IV

* Removal of lighter colored tattoo inks, including red and yellow inks, on Fitzpatrick skin types 1-111

1064nm (nano-second):

* Treatment of benign pigmented lesions on Fitzpatrick skin types 1-VI

* Removal of dark and multi-colored tattoos containing dark colored tattoo inks on Fitzpatrick skin types 1-VI

The handPICO@ Fraction Laser Handpiece Tip, when used with the Etherea-MX and Zye lasers at 1064 nm

in picosecond mode, is indicated for:

* Removal of tattoos on all skin types (Fitzpatrick skin types 1-VI) with the following tattoo colors: black,

brown, green, blue and purple.

* Treatment of benign pigmented lesions on Fitzpatrick skin types 1-IV.

* Treatment of acne scars in Fitzpatrick Skin Types II-V.

* Treatment of wrinkles in Fitzpatrick Skin Types 1-IV.

The Zye Ultra is indicated for:

755 nm:

Intended for the temporary and permanent hair reduction on all skin types (Fitzpatrick 1-VI), including tanne

skin. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and

12 months after the end of a treatment regime; epidermal lesions (benign pigmented lesions) such as solar

melanosis, hyperpigmentation, melasma, and ephelides, wrinkles, treatment of benign cutaneous lesions

with vascular components including port wine stains, hemangiomas, facial and bodily telangiectasia,

erythematous rosacea, angiomas and spider angiomas

poikiloderma of Civatte and superficial venous malformations.

1064nm

In long pulse mode, the ZYE YAG® applicator is designated for coagulation and hemostasis of vascular

lesions and epidermal tissue, including the treatment of telangiectasia, superficial varicosities, angiomas

and spider angiomas, hemangiomas, rosacea, and nevi. It is also designated for non-ablative treatment of

facial wrinkles and for removal of unwanted hair, for stable long term or permanent hair reduction

(permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when

measured at 6, 9 and 12 months after the completion of a treatment regimen); for the treatment of

pseudofolliculitis barbae (PFB). Use on all skin types (Fitzpatrick 1-VI), including tanned skin.

* In the DYNAMICS® mode, for temporary increase of clear nail in patients with onychomycosis (e.g.,

dermatophytes Trichophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans,

etc.).

* In the INTENSE® mode is intended for non-invasive Laser assisted lipolysis;

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K252753: Vydence Family of Lasers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252753

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026