CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND
Device Facts
| Record ID | K905453 |
|---|---|
| Device Name | CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND |
| Applicant | Douglas James Donaldson Compliance Services |
| Product Code | HQF · Ophthalmic |
| Decision Date | Mar 5, 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.
