Waterlase Express
Powered Laser Surgical Instrument
Biolase, Inc.
The following data is part of a premarket notification filed by Biolase, Inc. with the FDA for Waterlase Express.
Pre-market Notification Details
| Device ID | K161669 |
| 510k Number | K161669 |
| Device Name: | Waterlase Express |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Biolase, Inc. 4 Cromwell Irvine, CA 92618 |
| Contact | Alicia Mszyca |
| Correspondent | Alicia Mszyca Biolase, Inc. 4 Cromwell Irvine, CA 92618 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-16 |
| Decision Date | 2016-07-28 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00647529003626 | K161669 | 000 |
| 00647529003534 | K161669 | 000 |
| 00647529003459 | K161669 | 000 |
| 00647529002339 | K161669 | 000 |
| 00647529002315 | K161669 | 000 |
| 00647529003800 | K161669 | 000 |
| 00647529003480 | K161669 | 000 |
| 00647529003466 | K161669 | 000 |
| 00647529001509 | K161669 | 000 |
Trademark Results [Waterlase Express]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WATERLASE EXPRESS 87103870 5292447 Live/Registered |
Biolase, Inc. 2016-07-14 |
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