HRN · Unit, Cryophthalmic, Ac-Powered
Ophthalmic · 21 CFR 886.4170 · Class 2
Overview
| Product Code | HRN |
|---|---|
| Device Name | Unit, Cryophthalmic, Ac-Powered |
| Regulation | 21 CFR 886.4170 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II.
Cleared Devices (10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K200911 | MIRA Adapter | Phakos | Jun 2, 2020 | SESE |
| K180195 | Frigitronics adapter | Phakos | Mar 16, 2018 | SESE |
| K162756 | PHAKOS Disposable Retinal Cryo Probe | Phakos | May 3, 2017 | SESE |
| K160591 | D.O.R.C. Disposable Cryo Probe | Dutch Ophthalmic Research Center International BV | Jan 23, 2017 | SESE |
| K131787 | CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES | Keeler, Ltd. | Dec 23, 2013 | SESE |
| K112093 | CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER | Keeler Instruments, Inc. | Dec 8, 2011 | SESE |
| K062412 | CRYOMATIC | Keeler Instruments, Inc. | Nov 6, 2006 | SESE |
| K012821 | D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM | Dutch Ophthalmic USA, Inc. | Oct 22, 2001 | SESE |
| K992954 | KEELER CRYO MASTER & PROBES | Keeler Instruments, Inc. | Dec 21, 1999 | SESE |
| K823768 | CLIRANS TE08 HOLLOW FIBER DIALYZER | Terumo Medical Corp. | Jan 8, 1983 | SESE |
Top Applicants
- Phakos — 3 clearances
- Keeler Instruments, Inc. — 3 clearances
- Terumo Medical Corp. — 1 clearance
- Keeler, Ltd. — 1 clearance
- Dutch Ophthalmic USA, Inc. — 1 clearance
