1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 886 - OPHTHALMIC DEVICES
  6. Subpart B - Diagnostic Devices
  7. 21 CFR § 886.1385
21 CFR § 886.1385
Polymethylmethacrylate (PMMA) diagnostic contact lens
June 25, 2020
CFR

(a) Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.

(b) Classification. Class II.

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§ 886.1380 Diagnostic condensing lens
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§ 886.1390 Flexible diagnostic Fresnel lens

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