Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
IRIS Q-switched 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) - Removal of Benign Epidermal Pigmented Lesions - Minor Benign Vascular Lesions - Telangiectasias - Treatment of Lentigines - Cafe-Au-Lait - Seborrheic Keratoses - Becker's Nevi - Freckles - Treatment of Post Inflammatory Hyperpigmentation (PIH) 1064nm Wavelength: - Tattoo removal: dark ink (black, blue, green) - Removal of Nevus of Ota - Removal or lightening of unwanted hair with or without adjuvant preparation - Treatment of Common Nevi - Melasma - Skin resurfacing procedures for the treatment of acne scars, wrinkles
IRIS Q-switched 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), Removal of Benign Epidermal Pigmented Lesions, Minor Benign Vascular Lesions, Talangiectasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses, Becker's Nevi, Freckles Treatment of Post Inflammatory Hyperpigmentation (PIH). 1064nm Wavelength: Tattoo removal: dark ink (black, blue, green), Removal of Nevus of Ota, Removal or lightening of unwanted hair with or without adjuvant preparation, Treatment of Common Nevi, Melasma, Skin resurfacing procedures for the treatment of acne scars, wrinkle.
The IRIS Q-Switched Nd:YAG laser system produces a two pulsed beam, 1064 nm Infrared and 532nm long pulse laser, and using different Handpiece able to control various treatment fluence. Laser tube: placed in the mixed crystals of copper pipe to the heater and produces a laser beam, Resonator: amplifies the beam, through the Xe-gas contained lamp. This converted light energy creates the Nd:YAG crystal and exhaust from the crystal is amplified into a specific wave length. Laser energy produced is delivered to the Tissue by means of an articulated arm and a specially designed multi spot Hand Piece. The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using Foot Switch. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit. This system also consists of Optic main Bench assembly, Articulated Arm Hand pieces, LCD control panel, Cooling system, Foot Pedal Switch. This device has optional 180mm Dye Hand Pieces to able to switch to 585nm or 650nm from 532nm.
Summary parsed at:2026-06-01 06:00:17 UTC
