21 CFR § 886.4170 Ophthalmic Devices

§ 886.4170 Cryophthalmic unit.

Current through Sep 8, 2026 · Read all of Part 886

(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.

← § 886.4155 Scleral plug.§ 886.4230 Ophthalmic knife test drum. →