Vydence Family of Lasers

Vydence Medical Industria E Commercio Ltda

Country / region:Brazil (BR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K252753
Device name
Vydence Family of Lasers
Country / region
Brazil(BR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-08-29
Decision date
2026-01-24
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Acne treatmentPigment treatmentVascular treatmentHair removal
Primary application
Hair removal
Classification source
AI classified

Indications for Use

* The treatment of inflammatory acne (acne vulgaris);
* The treatment of leukoderma, including vitiligo (acquired leukoderma).
* 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).
* 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.

Intended Use

The treatment of inflammatory acne (acne vulgaris); The treatment of leukoderma, including vitiligo (acquired leukoderma). 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). 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.

Device Description

The Vydence Family of Lasers consists of five models of configurable platforms that include up to nine different handpieces. The Vydence Family has multiple modalities including IPL and IR handpieces. In addition, there is a variety of different wavelength laser handpieces including 1064nm, 532nm, 1540nm, 2940nm, 1340nm and 755nm. The Zye Ultra model has a feature that includes a blended mode which emits 755 nm Alex and 1064nm Nd:YAG laser energy sequentially.

Summary parsed at:2026-06-01 05:18:42 UTC

Predicate devices

3

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