AUTOMATIC CORNEAL SHAPER
Device Facts
| Record ID | K913697 |
|---|---|
| Device Name | AUTOMATIC CORNEAL SHAPER |
| Applicant | Hansa Research & Development, Inc. |
| Product Code | HNO · Ophthalmic |
| Decision Date | Nov 5, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4370 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.
