Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The CuRAS hybrid Nd:YAG laser system is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 532nm Wavelength: - Tattoo removal: light ink (red, tan, purple, orange, sky blue, green) - Removal of Epidermal Pigmented Lesions - Removal of Minor Vascular Lesions including but not limited to telangiectasias - Treatment of Lentigines - Treatment of Cafe-Au-Lait - Treatment of Seborrheic Keratoses - Treatment of Post Inflammatory Hyper-Pigmentation - Treatment of Becker's Nevi, Freckles and Nevi Spilus 1064nm 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: cafe-au-lait birthmarks, solar lentigines, senile lentigines, Becker's nevi, Freckles, Nevus spilus, seborrheic keratosis - Skin Resurfacing for Acne Scars and Wrinkles
The CuRAS hybrid Nd;YAG laser system is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 532nm Wavelength: - Tattoo removal: light ink (red, tan, purple, orange, skyblue, green) - Removal of Epidermal Pigmented Lesions - Removal of Minor Vascular Lesions including but not limited to telangiectasias - Treatment of Lentigines - Treatment of Cafe-Au-Lait - Treatment of Seborrheic Keratoses - Treatment of Post Inflammatory Hyper-Pigmentation - Treatment of Becker's Nevi, Freckles and Nevi Spilus. 1064nm Wavelength: - Tattoo removal: dark ink (black, blue and brown) - Removal of Nevus of Ota - Removal or lightening of unwanted hair with or without adjuvant preparation - Treatment of Common Nevi - Skin resurfacing procedures for the treatment of acne scars and wrinkles.
The CuRAS hybrid is a laser system indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis, at wavelengths of 532 nm and 1064 nm. In addition, optional dye handpieces provide output at wavelengths of 585 nm and 650 nm. The CuRAS hybrid system consists of a main unit, power cable, an articulated arm that transmits the laser energy, interchangeable handpieces, a footswitch, key switch, remote interlock connector, and operator/patient protective eyewear. The laser output is user-controlled via the footswitch.
Summary parsed at:2026-06-01 05:24:34 UTC
