AdvaTx

The AdvaTx is a non-ablative laser system with two wavelengths (589 nm and 1319 nm) used for dermatologic treatments. The 589 nm wavelength treats benign vascular lesions including wrinkles, telangiectasia, rosacea, port wine stains, hemangiomas, acne, warts, scars, striae, psoriasis, and pigmented lesions. The 1319 nm wavelength treats fine lines, wrinkles, atrophic acne scars, and mild to moderate inflammatory acne vulgaris.

The subject device shares the same technical characteristics as its predicate (AdvaTx K132976) with one modification: the fluence for the 1319 nm laser is increased from 40 J/cm² to 60 J/cm², matching the fluence of the reference device (TriStar). Both devices operate at the same wavelengths, pulse widths, repetition rates, and power supply specifications. The subject device has a smaller spot size (1.0 mm) compared to the predicate and reference devices (3–12 mm).

IEC 60601-1 Edition 3.2 (2020-08) for general medical electrical equipment safety; IEC 60601-1-2:2014 for electromagnetic compatibility; IEC 60601-2-22:2012 for surgical and therapeutic laser equipment; ISO 10993-1:2018 for biological evaluation; and software verification and validation per FDA guidance.

The subject device is substantially equivalent because it maintains identical intended use and indications as its predicate, operates on the same technological principles (selective photothermolysis), and differs only in a higher fluence parameter (60 J/cm² at 1319 nm) that is supported by the reference device. The increased fluence does not introduce new safety or efficacy concerns; rather, it aligns with established clinical parameters from reference devices. The smaller spot size also presents no additional safety risks and enables more precise treatment delivery.