The following data is part of a premarket notification filed by Biolase Technology, Inc. with the FDA for Epic 10.
| Device ID | K121286 |
| 510k Number | K121286 |
| Device Name: | EPIC 10 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOLASE TECHNOLOGY, INC. 4 CROMWELL Irvine, CA 92618 -1816 |
| Contact | Robert Yang |
| Correspondent | Robert Yang BIOLASE TECHNOLOGY, INC. 4 CROMWELL Irvine, CA 92618 -1816 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-30 |
| Decision Date | 2012-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00647529000120 | K121286 | 000 |
| 00647529000212 | K121286 | 000 |
| 00647529000267 | K121286 | 000 |
| 00647529000311 | K121286 | 000 |
| 00647529001783 | K121286 | 000 |
| 00647529001790 | K121286 | 000 |
| 00647529001806 | K121286 | 000 |
| 00647529000359 | K121286 | 000 |
| 00647529002643 | K121286 | 000 |
| 00647529000205 | K121286 | 000 |
| 00647529000199 | K121286 | 000 |
| 00647529000175 | K121286 | 000 |
| 00647529000137 | K121286 | 000 |
| 00647529001844 | K121286 | 000 |
| 00647529003824 | K121286 | 000 |
| 00647529004173 | K121286 | 000 |
| 00647529004357 | K121286 | 000 |
| 00647529004005 | K121286 | 000 |
| 00647529000151 | K121286 | 000 |
| 00647529000168 | K121286 | 000 |
| 00647529001837 | K121286 | 000 |
| 00647529001899 | K121286 | 000 |
| 00647529000441 | K121286 | 000 |
| 00647529002599 | K121286 | 000 |
| 00647529003237 | K121286 | 000 |
| 00647529003350 | K121286 | 000 |
| 00647529003367 | K121286 | 000 |
| 00647529003374 | K121286 | 000 |
| 00647529003381 | K121286 | 000 |
| 00647529003398 | K121286 | 000 |
| 00647529003404 | K121286 | 000 |
| 00647529002537 | K121286 | 000 |
| 00647529002520 | K121286 | 000 |
| 00647529002476 | K121286 | 000 |
| 00647529001936 | K121286 | 000 |
| 00647529001929 | K121286 | 000 |
| 00647529001912 | K121286 | 000 |
| 00647529001943 | K121286 | 000 |
| 00647529001813 | K121286 | 000 |
| 00647529001820 | K121286 | 000 |
| 00647529001967 | K121286 | 000 |
| 00647529002452 | K121286 | 000 |
| 00647529003411 | K121286 | 000 |