510(k) · Cleared
ClearedVydence Family of Lasers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
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.
- Root · 27 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 23 generations between
- 3 generations backK170597 PicoWay Laser SystemSyneron Candela Corporation · 2017
- 2 generations backK191685 PicoWay Laser SystemCandela Corporation · 2019
- 1 generation backK242534 HandPICO Fractional Laser Handpiece TipVydence Medical · 2024
- This deviceK252753 Vydence Family of LasersVydence Medical Industria E Commercio Ltda · 2026
Show all 27 generations
- Root · 27 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 26 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 25 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 24 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 23 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 22 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 21 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 20 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 19 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 18 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 17 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 16 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 15 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 14 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 13 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 12 generations backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- 11 generations backK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- 10 generations backK121346 Picosure WorkstationCynosure, Inc. · 2012
- 9 generations backK133364 Picosure WorkstationCynosure, Inc. · 2014
- 8 generations backK140719 Picosure WorkstationCynosure, Inc. · 2014
- 7 generations backK143105 Picosure WorkstationCynosure, Inc. · 2015
- 6 generations backK153527 PicoWay Laser SystemSyneron Candela Corporation · 2016
- 5 generations backK160607 PicoWay Laser SystemSyneron Candela Corporation · 2016
- 4 generations backK162454 PicoWay Laser SystemSyneron Candela Corporation · 2017
- 3 generations backK170597 PicoWay Laser SystemSyneron Candela Corporation · 2017
- 2 generations backK191685 PicoWay Laser SystemCandela Corporation · 2019
- 1 generation backK242534 HandPICO Fractional Laser Handpiece TipVydence Medical · 2024
- This deviceK252753 Vydence Family of LasersVydence Medical Industria E Commercio Ltda · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −27 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −26 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −25 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −24 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −23 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −22 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −21 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −20 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −19 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −18 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −17 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −16 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −15 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −14 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −13 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −12 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| −11 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
| −10 | K121346 | Picosure Workstation | Cynosure, Inc. | 2012 | — |
| −9 | K133364 | Picosure Workstation | Cynosure, Inc. | 2014 | — |
| −8 | K140719 | Picosure Workstation | Cynosure, Inc. | 2014 | — |
| −7 | K143105 | Picosure Workstation | Cynosure, Inc. | 2015 | — |
| −6 | K153527 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
| −5 | K160607 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
| −4 | K162454 | PicoWay Laser System | Syneron Candela Corporation | 2017 | — |
| −3 | K170597 | PicoWay Laser System | Syneron Candela Corporation | 2017 | — |
| −2 | K191685 | PicoWay Laser System | Candela Corporation | 2019 | — |
| −1 | K242534 | HandPICO Fractional Laser Handpiece Tip | Vydence Medical | 2024 | — |
| 0 (this device) | K252753 | Vydence Family of Lasers | Vydence Medical Industria E Commercio Ltda | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 12 | 0 |
| 1995 | 12 | 0 |
| 1996 | 17 | 0 |
| 1997 | 24 | 0 |
| 1998 | 15 | 0 |
| 1999 | 11 | 0 |
| 2000 | 26 | 0 |
| 2001 | 26 | 0 |
| 2002 | 35 | 0 |
| 2003 | 24 | 0 |
| 2004 | 17 | 0 |
| 2005 | 10 | 0 |
| 2006 | 7 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
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 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K190007 | Vydence Laser FamilySummary 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… | 2019 |
| * | K242534 | HandPICO Fractional Laser Handpiece TipSummary page 10…Product Code I K190007 Vydence Family of Lasers GEX,PDZ, Ob IK242534 I HandPico Fractional IGEX I K220041… | 2024 |
| * | K220041 | HandPICOSummary page 10…GEX,PDZ, Ob IK242534 I HandPico Fractional IGEX I K220041 I HandPico IGEX Device Description… | 2022 |
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 devicesGEX 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
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
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.
https://510kreport.com/device/K252753 · printed Nov 6, 2026
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