0ce8f1b0-ecf8-484e-ba87-03f360b3bafdUpdatePublished72023-08-162016-09-112023-08-10Not in Commercial Distribution07290109142463PrimaryGS1Multi-spot Nd:YAG SapphireCool Light Guide setMulti-spot Nd:YAG SapphireCool Light Guide set600166524LUMENIS LTD.1falsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse408-764-3000xxx@xxx.xxx45220Multi-modality skin surface treatment systemAn electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabrasion, oxygen skin application] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes energy/therapy sources (e.g., lasers, lamps, generator) and dedicated applicators (handpieces) intended to apply the different therapies to the skin.falseActiveONFPowered Light Based Non-Laser Surgical Instrument With Thermal EffectONGPowered Laser Surgical Instrument With Microbeam\Fractional OutputGEXPowered Laser Surgical Instrumentfalsefalse