Vydence Medical Industria E Comercio Ltda
Product code GEX· 21 CFR 878.4810
Product code
Predicate devices
FDA 510(k) registration fields
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 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; 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).
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Vydence Family of Lasers
1 submission cite K220041 as a predicate
