The following data is part of a premarket notification filed by Biovision, Inc. with the FDA for Crystal Focus Emerald Laser Slt Mcx 1.5 Convex Pro.
| Device ID | K910027 |
| 510k Number | K910027 |
| Device Name: | CRYSTAL FOCUS EMERALD LASER SLT MCX 1.5 CONVEX PRO |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOVISION, INC. 100 HEGENBERGER RD. SUITE 210 Oakland, CA 94621 |
| Contact | Douglas Donaldson |
| Correspondent | Douglas Donaldson BIOVISION, INC. 100 HEGENBERGER RD. 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 | 1991-01-03 |
| Decision Date | 1991-09-25 |