The following data is part of a premarket notification filed by Biolase, Inc with the FDA for Epic Pro 940.
| Device ID | K172771 |
| 510k Number | K172771 |
| Device Name: | Epic Pro 940 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-14 |
| Decision Date | 2017-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00647529003558 | K172771 | 000 |