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Vydence Laser Family

Vydence Medical Industria E Comercio Ltda

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

Product code GEX· 21 CFR 878.4810

Summary PDF

Company

Vydence Medical Industria E Comercio Ltda
Brazil (BR)

Product code

GEX
21 CFR 878.4810

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Device details

FDA 510(k) registration fields

K number
K190007
Device name
Vydence Laser Family
Company
Vydence Medical Industria E Comercio Ltda
Country / Region
Brazil(BR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2019-01-02
Decision date
2019-03-01
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Acne treatmentPigment treatmentVascular treatment
Primary application
Acne treatment
Classification source
AI classified

Indications for Use

• 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).

Intended Use

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).

Summary parsed at:2026-06-01 05:55:07 UTC

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Cited as predicate

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1 submission cite K190007 as a predicate