510(k) Report

510(k) · Cleared

Cleared

Vydence Laser Family

K190007510(k) TraditionalCleared Mar 1, 201958-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 Comercio Ltda · GEX Powered Laser Surgical Instrument

Cleared on Mar 1, 2019 after a 58-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided
Mar 1, 2019
Review
58 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2026: 1 descendant cleared201620182020202220242026
  1. This deviceK190007 Vydence Laser FamilyVydence Medical Industria E Comercio Ltda · 2019
  2. Descendant · cites it directly · 0 of its ownK252753 Vydence Family of LasersVydence Medical Industria E Commercio Ltda · 2026

Most influential descendants

Showing 1 of 1 · See all
  • K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K190007Vydence Laser FamilyVydence Medical Industria E Comercio Ltda2019—
+1K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K190007, 2019–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260

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?

  • Of its descendants, K252753 (Vydence Medical Industria E Commercio Ltda, 2026) has gone furthest, with 0 descendants of its own.

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. 2019, 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 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…

Read the full statement (1,856 words)

• 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 I-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, and cafè-aulait 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 an 12 months after the completion of a treatment regime.

• Use on Fitzpatrick skin types 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 I-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 I-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 I-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 I-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 I-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 backpain.

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 I-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); Cafè-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 perioral wrinkles.

• For use on all skin types (Fitzpatrick I-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 I-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

1340 ProDeep Handpiece

• non-ablative laser handpiece is intended for use in skin resurfacing

755nm Fiber Delivered Handpiece (Zye and One)

755nm

•Intended for the temporary and permanent hair reduction on all skin types (Fitzpatrick I-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; treatment of benign pigmented lesions; treatment of wrinkles; photocoagulation of dermatological vascular lesions, such as, but not limited to, port wine stains, hemangiomas and telangiectasias.

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 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 I-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.).

Indications for use as stated in the FDA 510(k) statement.

Cite this page

510(k) Report. “K190007: Vydence Laser Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190007

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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