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 including but not limited to: Nevus of Ota, Hori macules (nevus of Hori), and Melasma. 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 delivery system is indicated for tattoo removal and benign pigmented lesions removal in Skin Types I- III. The PicoSure 1064-nm delivery system is indicated for tattoo and benign pigmented lesions removal. Tattoo Removal (dark ink: blue and black) Dermal Pigmented Lesions; including but not limited to; Nevus of Ota, Lentigines, Nevi, Melasma and Café-au-lait Removal or lightening of hair with or without adjuvant preparation. Skin Resurfacing for Acne Scars and Wrinkles Benign cutaneous lesions; including but not limited to: striae and scars (excludes the 650nm wavelength) Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength) Tattoo removal (light ink: red, sky blue, green) Vascular lesions including but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi Epidermal Pigmented lesions; including, but not limited to: café-au-lait birthmarks, solar lentigines, senile lentigines, Becker's nevi, Freckles, Nevus spilus, seborrheic keratosis Skin Resurfacing for Acne Scars and Winkles Benign cutaneous lesions; including but not limited: striae and scars (excludes the 650nm wavelength) Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength)
The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal including but not limited to: Nevus of Ota, Hori macules (nevus of Hori), and Melasma. 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 delivery system is indicated for tattoo removal and benign pigmented lesions removal in Skin Types I-III. The PicoSure 1064-nm 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 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 05:42:42 UTC
