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510(k) Data Aggregation
K Number
K250189Device Name
AdvaTx
Manufacturer
Date Cleared
2025-04-01
(69 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
AdvaLight APS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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. Treatment of mild and moderate inflammatory acne vulgaris.
Device Description
The AdvaTx is non-ablative laser with two wavelengths: 1319nm and 589nm. There are multiple indications for use that are specific to each wavelength. 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.
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K Number
K132976Device Name
ADVATX
Manufacturer
Date Cleared
2014-04-17
(206 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ADVALIGHT APS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ADVATx at 589nm 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, striea, and psoriasis.
The ADVATx at 1319nm is indicated for treatment of fine lines and wrinkles. Treatment of atrophic acne scars. Treatment of mild and moderate inflammatory acne vulgaris.
Device Description
The ADVATx Laser System is a Nd:YAG laser delivering 589nm @-switched pulsed light and 1319nm continuous wave light. This laser system was developed specifically for dermatological treatments. The laser light is delivered to the patient either through a scanner or a hand piece.
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