The following data is part of a premarket notification filed by Pacific Quantum Instruments, Inc. with the FDA for Multiwave Xr.
| Device ID | K051876 |
| 510k Number | K051876 |
| Device Name: | MULTIWAVE XR |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PACIFIC QUANTUM INSTRUMENTS, INC. 408 BRYANT CIRCLE, SUITE F-1 Ojai, CA 93023 |
| Contact | Gennady L Nikolaenko |
| Correspondent | Gennady L Nikolaenko PACIFIC QUANTUM INSTRUMENTS, INC. 408 BRYANT CIRCLE, SUITE F-1 Ojai, CA 93023 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-11 |
| Decision Date | 2005-09-09 |
| Summary: | summary |