The following data is part of a premarket notification filed by Douglas James Donaldson Compliance Services with the FDA for Crystal Focus Emer Laser Photo Vis Red Oper Mode.
| Device ID | K912987 |
| 510k Number | K912987 |
| Device Name: | CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-08 |
| Decision Date | 1991-10-28 |