eCFR Reference Browser

---

title: "21 CFR §886.4170"

source: "https://www.ecfr.gov/current/title-21/section-886.4170"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "886"

part_subject: "OPHTHALMIC DEVICES"

subpart_code: "E"

subpart_subject: "Surgical Devices"

section_number: "886.4170"

section_subject: "Cryophthalmic unit."

cfr_reference: "21 CFR 886.4170"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

§886.4170 - Cryophthalmic unit.