Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The PicoLazer laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. 1064 nm The 1064 nm wavelength of the PicoLazer laser system is indicated for: • treatment of benign pigmented lesions on patients with all skin types (Fitzpatrick I-VI) • tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI) 532 nm The 532 nm wavelength of the PicoLazer laser system is indicated for: • treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III • tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III
The PicoLazer laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
The PicoLazer Laser System is a multi-wavelength laser system that operates at 1064 nm and 532 nm wavelengths. The 1064 nm wavelength is indicated for the treatment of benign pigmented lesions and tattoo removal for dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI). The 532 nm wavelength is indicated for the treatment of benign pigmented lesions and tattoo removal for lighter colored tattoo inks on patients with Fitzpatrick skin types I-III.
Summary parsed at:2026-06-01 05:46:54 UTC
