The following data is part of a premarket notification filed by Douglas James Donaldson Compliance Services with the FDA for Crystal Focus Emerald Laser/slt Ophf 0.6 Endo Hand.
| Device ID | K905453 |
| 510k Number | K905453 |
| Device Name: | CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND |
| Classification | Laser, Ophthalmic |
| Applicant | DOUGLAS JAMES DONALDSON COMPLIANCE SERVICES 100 HEGENBERGER ROAD, SUITE 210 Oakland, CA 94621 |
| Contact | Douglas Donaldson |
| Correspondent | Douglas Donaldson DOUGLAS JAMES DONALDSON COMPLIANCE SERVICES 100 HEGENBERGER ROAD, SUITE 210 Oakland, CA 94621 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-05 |
| Decision Date | 1991-03-05 |