MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE
Device Facts
| Record ID | K844668 |
|---|---|
| Device Name | MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE |
| Applicant | Cooper Lasersonics, Inc. |
| Product Code | HQF · Ophthalmic |
| Decision Date | Jan 3, 1985 |
| 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.
