Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The PICOHI is indicated for the following at the specified wavelength: • 532 nm: Removal of tattoos for Fitzpatrick skin types I‐III to treat the following tattoo colors: red, yellow and orange. • 1064 nm: Removal of tattoos for all skin types (Fitzpatrick I‐VI) to treat the following tattoo colors: black, brown, green, blue and purple. • Treatment of benign pigmented lesions for Fitzpatrick skin types I-IV.
The PICOHI is indicated for the following at the specified wavelength: • 532 nm: Removal of tattoos for Fitzpatrick skin types I‐III to treat the following tattoo colors: red, yellow and orange. • 1064 nm: Removal of tattoos for all skin types (Fitzpatrick I‐VI) to treat the following tattoo colors: black, brown, green, blue and purple. • Treatment of benign pigmented lesions for Fitzpatrick skin types I-IV.
The PICOHI is a solid-state laser capable of delivering energy at wavelengths of 1064nm, 532nm at extremely short duration in the range of 275‐300ps. The laser system contains one 1064nm (Nd:YAG) laser head which is used to create the 1064nm picosecond wavelength which can be frequency‐doubled to 532nm as desired. The outputs of the two lasers are designed to be co‐linear on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 1064nm or 532nm wavelengths. All these energies are delivered through an articulated arm and corresponding handpiece.
Summary parsed at:2026-06-01 05:41:22 UTC
