HQA · Unit, Cryotherapy, Ophthalmic
Ophthalmic · 21 CFR 886.4170 · Class 2
Overview
| Product Code | HQA |
|---|---|
| Device Name | Unit, Cryotherapy, Ophthalmic |
| 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K854422 | SERIES 25 SLIMLINE CRYO PROBES | Keeler Instruments, Inc. | Dec 30, 1985 | SESE |
| K854411 | KEELER-COMPACT CRYO SYSTEM | Keeler Instruments, Inc. | Dec 30, 1985 | SESE |
| K841294 | ACU220 CRYO UNIT | Keller Instruments, Inc. | Aug 15, 1984 | SESE |
| K823835 | SPEMBLY 140 CRYOSYSTEM PROBES & TIPS | Keller Instruments, Inc. | Jan 17, 1983 | SESE |
Top Applicants
- Keeler Instruments, Inc. — 2 clearances
- Keller Instruments, Inc. — 2 clearances
