title: Medical devices; ophthalmic devices; classification of the eyelid thermal pulsation system. Final rule.
abstract: The Food and Drug Administration (FDA) is classifying the eyelid thermal pulsation system into class II (special controls). 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.
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence; D015352:Dry Eye Syndromes / Q000628:therapy; D004867:Equipment Design; D004869:Equipment Safety / Q000145:classification*; D005143:Eyelids; D006801:Humans; D006979:Hyperthermia, Induced / Q000145:classification / Q000295:instrumentation*; D009885:Ophthalmology / Q000145:classification / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration