OPHTHALMIC CRYO UNIT
Device Facts
| Record ID | K940373 |
|---|---|
| Device Name | OPHTHALMIC CRYO UNIT |
| Applicant | Dutch Ophthalmic USA, Inc. |
| Product Code | HPS · Ophthalmic |
| Decision Date | Jul 18, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| 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.
