HPS · Unit, Cryophthalmic
Ophthalmic · 21 CFR 886.4170 · Class 2
Overview
| Product Code | HPS |
|---|---|
| Device Name | Unit, Cryophthalmic |
| 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.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K202038 | CryoTreQ | VitreQ BV | Dec 30, 2020 | SESE |
| K940373 | OPHTHALMIC CRYO UNIT | Dutch Ophthalmic USA, Inc. | Jul 18, 1994 | SESE |
| K923629 | OPHTHALMIC TRICHIASIS PROBE | Mira, Inc. | Oct 19, 1992 | SESE |
| K903303 | SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES | Spembly Medical , Ltd. | Oct 11, 1990 | SESE |
| K874555 | KEELER ACU 22XT OPHTHALMIC CRYO UNIT | Keeler Instruments, Inc. | Jan 29, 1988 | SESE |
| K873388 | KEELER CTU CRYO SYSTEM | Keeler Instruments, Inc. | Nov 13, 1987 | SESE |
| K870195 | UNITED SURGICAL CORP. CRYOPTIC PLUS | United Surgical Corp. | Feb 20, 1987 | SESE |
| K833747 | GALLIE CRYONUCLEATOR | Mono Research Laboratories | May 9, 1984 | SESE |
| K801418 | KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT | Keeler Optical Products , Ltd. | Jul 21, 1980 | SESE |
| K790102 | MODEL 556-01 CRYOEXTRACTOR | Intermedics, Inc. | Feb 12, 1979 | SESE |
| K781338 | BEAVER CATARACT CYROXTRACTOR | Edward Weck, Inc. | Feb 12, 1979 | SESE |
Top Applicants
- Keeler Instruments, Inc. — 2 clearances
- VitreQ BV — 1 clearance
- United Surgical Corp. — 1 clearance
- Spembly Medical , Ltd. — 1 clearance
- Mono Research Laboratories — 1 clearance
