GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE
Device Facts
| Record ID | K954306 |
|---|---|
| Device Name | GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE |
| Applicant | Gamp & Assoc. |
| Product Code | HQB · Ophthalmic |
| Decision Date | Dec 22, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4690 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an extended noncoherent light source to occlude blood vessels of the retina, choroid, or iris.