title: Medical devices; general and plastic surgery devices; classification of the low level laser system for aesthetic use. Final rule.
abstract: The Food and Drug Administration (FDA) is classifying the low level laser system for aesthetic use into class II (special controls). The special control(s) that will apply to the device is entitled ``Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.'' The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device type.
mesh_terms: D018795:Device Approval; D004869:Equipment Safety / Q000145:classification*; D006801:Humans; D053685:Laser Therapy / Q000145:classification* / Q000295:instrumentation; D007834:Lasers / Q000009:adverse effects / Q000145:classification*; D013518:Surgery, Plastic / Q000295:instrumentation*; D014481:United States