VANISH PRO

The VANISH PRO is a Q-switched Nd:YAG laser system intended for dermatological and aesthetic procedures including tattoo removal, treatment of benign vascular and pigmented lesions, and skin resurfacing. It operates at 1064 nm and 532 nm wavelengths in Q-switched and picosecond modes for conditions such as melasma, café au lait macules, acne scars, wrinkles, and various types of nevi.

The VANISH PRO is a solid-state, Q-switched Nd:YAG laser emitting nanosecond pulses at 1064 nm with similar pulse energy, repetition frequency, and modes of operation as predicate devices. Output parameters fall within the range of predicate devices, though there are slight differences in pulse train numbers. The device uses the same laser system, conduit, and electrical configuration as the predicate POLYLASE device and includes a new handpiece without electrical components.

Software verification and validation testing was conducted in accordance with FDA guidance on 'Content of Premarket Submissions for Device Software Functions.' Output parameters were validated via independent bench testing. No biocompatibility or electrical/EMC testing was required based on predicate device clearance history.

The VANISH PRO is substantially equivalent to predicates K213569 (HOLLYWOOD SPECTRA Laser System) and K202503 (Chrome) because it operates on identical principles as solid-state Q-switched Nd:YAG lasers, maintains output parameters within predicate ranges, uses identical laser system and electrical configuration to previously cleared devices, and does not raise new questions of safety or effectiveness.