Epic Pro
Powered Laser Surgical Instrument
Biolase, Inc
The following data is part of a premarket notification filed by Biolase, Inc with the FDA for Epic Pro.
Pre-market Notification Details
| Device ID | K163128 |
| 510k Number | K163128 |
| Device Name: | Epic Pro |
| 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 | 2016-11-08 |
| Decision Date | 2017-01-11 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00617529003220 | K163128 | 000 |
| 00647529003220 | K163128 | 000 |
| 00647529003190 | K163128 | 000 |
| 00647529003206 | K163128 | 000 |
| 00647529002605 | K163128 | 000 |
| 00647529003473 | K163128 | 000 |
Trademark Results [Epic Pro]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EPIC PRO 87124429 5292538 Live/Registered |
Biolase, Inc. 2016-08-02 |
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