FDA regulation of black box lasers: approximately 50% of users opt to submit investigational device exemptions.
Mandle
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D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety; D006801:Humans; D054018:Lasers, Excimer; D018903:Photorefractive Keratectomy / Q000295:instrumentation* / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*