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Title 21 Part 886 → Subpart E → §886.4170

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart E → §886.4170

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart E → §886.4170

e-CFR data is current as of August 22, 2019

Title 21Chapter ISubchapter HPart 886Subpart E → §886.4170


Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart E—Surgical Devices


§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.