PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB
Device Facts
| Record ID | K011195 |
|---|---|
| Device Name | PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB |
| Applicant | Surgin Surgical Instrumentation, Inc. |
| Product Code | HNO · Ophthalmic |
| Decision Date | Nov 6, 2001 |
| 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.
