Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The PICOCAREMAJESTY is indicated for the following at the specified wavelength: * 1064 nm: Removal of tattoos for all skin types (Fitzpatrick I - VI) to treat the following tattoo colors: black, brown, green, blue and purple. * 532 nm: Removal of tattoos for Fitzpatrick skin types I - III to treat the following tattoo colors: red, yellow and orange. * Treatment of benign pigmented lesions for Fitzpatrick skin types I-IV.
The PICOCAREMAJESTY is indicated for the following at the specified wavelength: * 1064 nm: Removal of tattoos for all skin types (Fitzpatrick I - VI) to treat the following tattoo colors: black, brown, green, blue and purple. * 532 nm: Removal of tattoos for Fitzpatrick skin types I - III to treat the following tattoo colors: red, yellow and orange. * Treatment of benign pigmented lesions for Fitzpatrick skin types I-IV.
The PICOCAREMAJESTY is the solid state laser capable of delivering energy at wavelengths of 1064nm or 532nm at short durations. 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. For treatment, the user can select the appropriate fluence value. (The treatment parameters recommended is provided in the user Manual) The energy is changed automatically in accordance with the selected fluence (down) button and then, the fluence is increased / decreased by 0.1 J/cm2. The selectable fluence values are 0.2 to 10.0 J/cm2 at 1064nm and 0.1 to 2.5 J/cm2 at 532nm.
Summary parsed at:2026-06-01 05:28:12 UTC
