WATERLASE MD
Powered Laser Surgical Instrument
BIOLASE TECHNOLOGY, INC.
The following data is part of a premarket notification filed by Biolase Technology, Inc. with the FDA for Waterlase Md.
Pre-market Notification Details
| Device ID | K083927 |
| 510k Number | K083927 |
| Device Name: | WATERLASE MD |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOLASE TECHNOLOGY, INC. 4 CROMWELL Irvine, CA 92618 -1816 |
| Contact | Ioanna Rizou |
| Correspondent | Ioanna 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 | 2008-12-31 |
| Decision Date | 2009-10-01 |
| Summary: | summary |
Trademark Results [WATERLASE MD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WATERLASE MD 77185280 3587923 Live/Registered |
BIOLASE, INC. 2007-05-18 |
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