21 CFR 886.4170 - Cryophthalmic unit.

§ 886.4170 Cryophthalmic unit.

(a)Identification. A cryophthalmic unit is a device that is a probe with a small tip that becomes extremely cold through the controlled use of a refrigerant or gas. The device may be AC-powered. The device is intended to remove cataracts by the formation of an adherent ice ball in the lens, to freeze the eye and adjunct parts for surgical removal of scars, and to freeze tumors.

(b)Classification. Class II.

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United States Code

Title 21 published on 09-Nov-2018 03:23

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 886 after this date.

  • 2018-10-19; vol. 83 # 203 - Friday, October 19, 2018
    1. 83 FR 52973 - Medical Devices; Ophthalmic Devices; Classification of the Intranasal Electrostimulation Device for Dry Eye Symptoms
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective October 19, 2018. The classification was applicable on May 17, 2018.
      21 CFR Part 886