Code of Federal Regulations · Section
§ 886.5100 — Ophthalmic Beta Radiation Source
21 C.F.R. § 886.5100
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(a) Identification. An ophthalmic beta radiation source is a device intended to apply superficial radiation to benign and malignant ocular growths.
(b) Classification. Class II.
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351