c65b2956-8888-4d4a-9850-2e3a3cf2bcb3UpdatePublished82025-02-262016-08-242023-08-10Not in Commercial Distribution07290109141015PrimaryGS1SapphireCool Light Guide 15 × 35 mmSapphireCool Light Guide 15 × 35 mm600166524LUMENIS LTD.1falsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling 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.falseActiveGEXPowered Laser Surgical InstrumentONGPowered Laser Surgical Instrument With Microbeam\Fractional OutputONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effectfalsefalse