Manufacturer
Vydence Medical Industria E Commercio LtdaVydence Family of Lasers
Vydence Medical Industria E Commercio Ltda
Country / Region:Brazil (BR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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
3Vydence Laser Family
HandPICO
HandPICO Fractional Laser Handpiece Tip
K252753 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K252753 as a predicate
