Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The ADVATx at 589 nm is indicated for use for dermatologic treatment of benign cutaneous vascular lesions including but not limited to: treatment of wrinkles, periocular wrinkles, periorbital wrinkles, facial and leg telangiectasia, rosacea, cherry angiomas, port wine stains, hemangiomas, venous lakes, angioma, spider angioma, Poikiloderma of Civatte, inflammatory acne vulgaris, verrucae/warts, scars, striae, psoriasis and the treatment of benign pigmented lesions. The ADVATx at 1319 nm is indicated for treatment of fine lines and wrinkles, treatment of atrophic acne scars, and treatment of mild and moderate inflammatory acne vulgaris.
The ADVATx at 589 nm is indicated for use for dermatologic treatment of benign cutaneous vascular lesions including but not limited to: treatment of wrinkles, periocular wrinkles, periorbital wrinkles, facial and leg telangiectasia, rosacea, cherry angiomas, port wine stains, hemangiomas and venous lakes, angioma, spider angioma, Poikiloderma of Civatte, inflammatory acne vulgaris, verrucae/ warts, scars, striae, psoriasis and the treatment of benign pigmented lesions. The ADVATx at 1319 nm is indicated for treatment of fine lines and wrinkles, treatment of atrophic acne scars, and treatment of mild and moderate inflammatory acne vulgaris.
The AdvaTx is a non-ablative laser with two wavelengths: 1319nm and 589nm. The AdvaTx consists of a console, a handpiece that has a scanner and a distance guide. The laser is activated using a trigger that is located on the handpiece. The AdvaTx produces light pulses with a specific duration, intensity, and spectral distribution allowing for a controlled and confined energy delivery into tissue. Laser use in dermatology relies on the basis that certain targets for energy absorption (chromophores) are capable of absorbing energy from the specific light wavelength (absorptive band) without exclusively being targeted by their highest absorption peak. The working basis of the laser rests on the principle of selective photothermolysis, in which thermally mediated radiation damage is confined to chosen epidermal and/or dermal pigmented targets at the cellular or tissue structural levels.
Summary parsed at:2026-06-01 05:22:15 UTC
