INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM
Device Facts
| Record ID | K890509 |
|---|---|
| Device Name | INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM |
| Applicant | Biophysic Medical, Inc. |
| Product Code | HQF · Ophthalmic |
| Decision Date | Mar 24, 1989 |
| 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.
