CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
Device Facts
| Record ID | K112093 |
|---|---|
| Device Name | CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER |
| Applicant | Keeler Instruments, Inc. |
| Product Code | HRN · Ophthalmic |
| Decision Date | Dec 8, 2011 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 886.4170 |
| Device Class | Class 2 |
Regulatory Classification
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.
