PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480
Device Facts
| Record ID | K912112 |
|---|---|
| Device Name | PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 |
| Applicant | Tomey Corporation USA |
| Product Code | LQJ · Ophthalmic |
| Decision Date | Jun 17, 1991 |
| 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.
