The following data is part of a premarket notification filed by Biolase Technology, Inc. with the FDA for Laserspray(tm).
| Device ID | K950248 |
| 510k Number | K950248 |
| Device Name: | LASERSPRAY(TM) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOLASE TECHNOLOGY, INC. 981 CALLE AMANECER San Clemente, CA 92673 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-20 |
| Decision Date | 1995-02-24 |