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 |