1. Regulations
  2. title 21
  3. chapter I-i7
  4. part 886
  5. subpart E
  6. § 886.4670

View all text of Subpart E [§ 886.4070 - § 886.4855]

§ 886.4670 - Phacofragmentation system.

(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.

AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360

SOURCE: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.

CITE AS: 21 CFR 886.4670