21 CFR § 886.4170 - Cryophthalmic unit.

---
identifier: "/us/cfr/t21/s886.4170"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 886.4170 - Cryophthalmic unit."
title_number: 21
title_name: "Food and Drugs"
section_number: "886.4170"
section_name: "Cryophthalmic unit."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "886"
part_name: "OPHTHALMIC DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 33355, Sept. 2, 1987, unless otherwise noted."
cfr_part: "886"
---


# 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.