PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES
Device Facts
| Record ID | K002849 |
|---|---|
| Device Name | PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES |
| Applicant | Surgical Specialties Corp |
| Product Code | HNO · Ophthalmic |
| Decision Date | Oct 18, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4370 |
| Device Class | Class 1 |
| Attributes | 3rd-Party Reviewed |
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.
