title: FDA regulation of black box lasers: approximately 50% of users opt to submit investigational device exemptions.
authors.forename: M
authors.initials: M
authors.lastname: Mandle
mesh_terms: 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*