NIDEK MODEL GYC-1500 AND GYC-2000
Device Facts
| Record ID | K951079 |
|---|---|
| Device Name | NIDEK MODEL GYC-1500 AND GYC-2000 |
| Applicant | Nidek, Inc. |
| Product Code | HQF · Ophthalmic |
| Decision Date | Sep 14, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4390 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.
