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 E - Surgical Devices
  7. 21 CFR § 886.4670
21 CFR § 886.4670
Phacofragmentation system
June 25, 2020
CFR

(a) Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

(b) Classification. Class II.

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§ 886.4610 Ocular pressure applicator
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§ 886.4690 Ophthalmic photocoagulator

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