The following data is part of a premarket notification filed by Biolase Technology, Inc. with the FDA for Waterlase Iplus All Tissue Laser.
| Device ID | K122368 |
| 510k Number | K122368 |
| Device Name: | WATERLASE IPLUS ALL TISSUE LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOLASE TECHNOLOGY, INC. 4 CROMWELL Irvine, CA 92618 |
| Contact | Ehab Esmail |
| Correspondent | Ehab Esmail BIOLASE TECHNOLOGY, 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 | 2012-08-06 |
| Decision Date | 2013-05-02 |
| Summary: | summary |