The following data is part of a premarket notification filed by Biolase, Inc. with the FDA for Epic 980.
| Device ID | K192430 |
| 510k Number | K192430 |
| Device Name: | Epic 980 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-05 |
| Decision Date | 2019-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00647529003817 | K192430 | 000 |
| 00647529004166 | K192430 | 000 |
| 00647529004159 | K192430 | 000 |