The following data is part of a premarket notification filed by Biolase Technology, Inc. with the FDA for Ezlase 3 Laser System.
| Device ID | K093852 |
| 510k Number | K093852 |
| Device Name: | EZLASE 3 LASER SYSTEM |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-16 |
| Decision Date | 2010-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00647529002551 | K093852 | 000 |
| 00647529002322 | K093852 | 000 |
| 00647529002308 | K093852 | 000 |
| 00647529001332 | K093852 | 000 |