The following data is part of a premarket notification filed by Biolase, Inc. with the FDA for Epic 10.
| Device ID | K140120 |
| 510k Number | K140120 |
| Device Name: | EPIC 10 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOLASE, INC. 4 CROMWELL Irvine, CA 92618 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell 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 | 2014-01-16 |
| Decision Date | 2014-10-10 |
| Summary: | summary |