The following data is part of a premarket notification filed by Biolase Technology, Inc. with the FDA for Waterlase And Waterlase Md.
| Device ID | K071363 |
| 510k Number | K071363 |
| Device Name: | WATERLASE AND WATERLASE MD |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOLASE TECHNOLOGY, INC. 4 CROMWELL Irvine, CA 92618 -1816 |
| Contact | Ioana Rizou |
| Correspondent | Ioana Rizou BIOLASE TECHNOLOGY, INC. 4 CROMWELL Irvine, CA 92618 -1816 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-15 |
| Decision Date | 2008-02-12 |
| Summary: | summary |