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§ 886.4170 Cryophthalmic unit.

21 CFR 886.4170

Citation21 CFR 886.4170
CorpusDaily eCFR
Displayed edition2026-04-27
Last updated2026-04-27

§ 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.