OPTOSCALPEL I LASER SYSTEM
Device Facts
| Record ID | K923531 |
|---|---|
| Device Name | OPTOSCALPEL I LASER SYSTEM |
| Applicant | Optomed Corp. |
| Product Code | HQB · Ophthalmic |
| Decision Date | Nov 12, 1993 |
| 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.
