Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The Picocare is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. The 1064 nm wavelength of the Picocare system is indicated for 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). The 532 nm wavelength of the Picocare system is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.
The Picocare is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. The 1064 nm wavelength of the Picocare system is indicated for 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). The 532 nm wavelength of the Picocare system is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.
The Picocare is the solid state laser capable of delivering energy at wavelengths of 1,064 nm or 532 nm at short durations of 750 ps (picoseconds). The device system consists of a main unit, an articulated arm, a handpiece and a foot switch. The laser output is delivered to the skin through the articulated arm delivery system terminated by the handpiece. The fluence (energy density) and frequency are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.
Summary parsed at:2026-06-01 05:59:00 UTC
