Alma Veil

The Alma Veil is a Nd:YAG laser system operating at 1064 nm and 532 nm wavelengths, intended for surgical and aesthetic applications in dermatology, general surgery, and plastic surgery. It treats vascular lesions, pigmented lesions, tattoos, wrinkles, and performs hair reduction through laser-induced coagulation and hemostasis of skin tissue.

The Alma Veil uses a flashlamp-pumped solid-state laser with dual wavelengths (1064 nm and 532 nm), maximum 10 Hz repetition rate, fluence range 2–300 J/cm² at 1064 nm and 1.8–42 J/cm² at 532 nm, and includes a cooling system in the handpiece. Differences from the predicate (V-Laser) are cosmetic and ergonomic: darkish gray color instead of white/light gray, mesh-type fiber cable, updated GUI, handpiece tip holder addition, and NEMA L6-20P to IEC 60884-1 plug conversion for regional markets.

Device tested against AASI AAMI ES60601-1:2005/(R)2012 and A1:2012 (electrical safety), ANSI AAMI IEC 60601-1-2:2014 (electromagnetic compatibility), IEC 60601-1-6 Edition 3.1 2013 (usability), IEC 60601-2-22 Edition 4 2014 (surgical laser equipment), and IEC 60825-1:2014 (laser product safety). Software validation performed per FDA guidance for moderate-level concern software.

The Alma Veil is substantially equivalent because it shares identical intended use, anatomical site, principle of operation, wavelengths, repetition rate, laser media, and aiming beam with the predicate V-Laser (K231054). All design and technical differences are cosmetic or ergonomic modifications for marketing/regional purposes that do not affect safety or effectiveness. The patient-contacting materials (stainless steel and sapphire) are identical, biocompatibility is confirmed, and all regulatory performance standards are met identically to the predicate device.