The following data is part of a premarket notification filed by Biolase Technology, Inc. with the FDA for Epic 10s.
| Device ID | K130465 |
| 510k Number | K130465 |
| Device Name: | EPIC 10S |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOLASE TECHNOLOGY, INC. 4 CROMWELL Irvine, CA 92618 -1816 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell BIOLASE TECHNOLOGY, INC. 4 CROMWELL Irvine, CA 92618 -1816 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-25 |
| Decision Date | 2013-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00647529003640 | K130465 | 000 |
| 00647529002575 | K130465 | 000 |
| 00647529001851 | K130465 | 000 |
| 00647529001882 | K130465 | 000 |
| 00647529001875 | K130465 | 000 |
| 00647529001868 | K130465 | 000 |
| 00647529000236 | K130465 | 000 |