Product code GEX· 21 CFR 878.4810
Product code
Predicate devices
Cited as predicate
FDA 510(k) registration fields
The Skin Care system is intended for aesthetic and cosmetic applications and for selective treatments required by medical dermatology specialties. The skin care system and optional Hand pieces with 420 - 1050 nm wavelengths, with and without contact cooling, is indicated for, but not limited to: * Hair removal and Permanent Hair Reduction in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelengths in the range of 670-1050 nm, 755-950 nm or 580-1050 nm * Treatment of Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 515-950 nm * Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 420-950 nm * Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 560-950 nm Permanent hair reduction 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 regimen.
The Skin Care system is intended for aesthetic and cosmetic applications and for selective treatments required by medical dermatology specialties. The skin care system and optional Hand pieces with 420 - 1050 nm wavelengths, with and without contact cooling, is indicated for, but not limited to: Hair removal and Permanent Hair Reduction in all skin types (I-VI) to the Fitzpatrick scale; Treatment of Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale; Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale; Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale.
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