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 handpieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV. The PicoSure 532 nm delivery system is indicated for tattoo removal and benign pigmented lesion 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 handpieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV. The PicoSure 532 nm delivery system is indicated for tattoo removal and benign pigmented lesion 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 755nm handpiece, optional 532nm Laser Delivery System and/or 1064nm Laser Delivery System can replace the 755nm handpiece at the distal end of the articulated arm. These Delivery Systems convert the 755nm laser energy into a 532nm wavelength or a 1064 nm wavelength, and are available in multiple spot sizes.
Summary parsed at:2026-06-01 05:56:29 UTC
