MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC
Device Facts
| Record ID | K870839 |
|---|---|
| Device Name | MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC |
| Applicant | Directed Energy, Inc. |
| Product Code | HQF · Ophthalmic |
| Decision Date | May 22, 1987 |
| 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.
