ARGON/KRYPTON LASER SYSTEM 8500
Device Facts
| Record ID | K844209 |
|---|---|
| Device Name | ARGON/KRYPTON LASER SYSTEM 8500 |
| Applicant | Cooper Lasersonics, Inc. |
| Product Code | HQB · Ophthalmic |
| Decision Date | Feb 6, 1985 |
| 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.