Venus Viva™ System Sample Clauses

Venus Viva™ System. The Venus Viva™ system is a fractional RF system that is intended for dermatological procedures requiring ablation and resurfacing of the skin. The Venus Viva™ device is a non-significant risk device. Consistent with 21 CFR 812.66, the device does NOT meet the criteria for significant risk device: o It is not an implant and does not present a potentially serious risk. o The device does not support or sustain human life, or present a potential for serious risk. o The device is not used for a substantial importance in: diagnosing, curing, mitigating, or treating disease, or preventing impairment of health. The investigational device could not cause significant harm to any of the subjects. The device could not cause any of the following potential harmful situations. • Life threatening • Permanent damage to body function • Permanent damage to body structure • Necessitate medical or surgical intervention • Preclude permanent impairment of a body function • Preclude permanent damage to body structure The device does not appear on the FDA significant risk device list.
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