The following data is part of a premarket notification filed by Biolase Technology, Inc. with the FDA for Ezlase 10w.
| Device ID | K083069 |
| 510k Number | K083069 |
| Device Name: | EZLASE 10W |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOLASE TECHNOLOGY, INC. 4 CROMWELL Irvine, CA 92618 -1816 |
| Contact | Ioana Rizoiu |
| Correspondent | Ioana Rizoiu BIOLASE TECHNOLOGY, INC. 4 CROMWELL Irvine, CA 92618 -1816 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-15 |
| Decision Date | 2008-11-13 |
| Summary: | summary |