Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The PicoLO laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. The 1064nm wavelength of the PicoLO laser system is indicated for tattoo removal for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. The 532nm wavelength of the PicoLO laser system is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. The PicoLO laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The 1064 handpiece (1064nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V. The PicoLO laser system is also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.
PicoLO laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. The 1064nm wavelength of the PicoLO laser system is indicated for tattoo removal for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. The 532nm wavelength of the PicoLO laser system is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. The PicoLO laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The 1064 handpiece (1064nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V. The PicoLO laser system is also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.
The PicoLO laser system is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm). The PicoLO Nd:YAG Picosecond Laser System consists of a set of Q-switched Nd:YAG lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.
Summary parsed at:2026-06-01 05:42:22 UTC
