Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure workstation with the 2mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I - IV. The PicoSure 532 nm Laser Delivery System is indicated for tattoo removal in Skin Types I - III. The PicoSure 1064 nm Laser Delivery System is indicated for tattoo and benign pigmented lesions removal.
The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure workstation with the 2mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I - IV. The PicoSure 532 nm Laser Delivery System is indicated for tattoo removal in Skin Types I - III. The PicoSure 1064 nm Laser Delivery System is indicated for tattoo and benign pigmented lesions removal.
The PicoSure™ workstation is a high-powered, Alexandrite system that delivers laser energy in the 755-nm nominal wavelength. The system offers fast and efficient treatment through a variety of spot sizes, fluences and repetition rates. Laser activation is by footswitch. In addition to the 755 nm handpiece, optional 532 nm Laser Delivery System and/or 1064 nm Laser Delivery System can replace the 755 nm handpiece at the distal end of the articulated arm. These Delivery Systems convert the 755 nm laser energy into a 532 nm wavelength or a 1064 nm wavelength and are available in multiple spot sizes.
Summary parsed at:2026-06-01 06:05:58 UTC
