5762d719-1be3-4711-8773-4a01f260ffd5UpdatePublished32018-07-062016-09-24In Commercial Distribution07290016540406PrimaryGS107290016540512PackageGS1072900165404061In Commercial DistributionSR580 applicatorAS120032533127663VENUS CONCEPT LTD1IPL applicator. Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides
(freckles), lentigines, nevi, and cafe-au-lait macules. Treatment of benign cutaneous vascular lesions including: port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of civatte, leg veins and venous malformationsfalsefalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK15371700045222Light-energy skin surface treatment system applicatorA handpiece that is part of a skin surface treatment system that conducts one or more generated light energies [e.g., fluorescent, ultraviolet B (UVB)] used for ablative and non-ablative treatment of skin conditions (e.g., acne, psoriasis, vascular lesions, wrinkles, large pores). This device is connected to a generator and is applied by the practitioner or staff directly to the area to be treated. This is a reusable device.falseActiveONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effectfalsefalse