The following data is part of a premarket notification filed by Emvera Technologies, Inc. with the FDA for Emvera Diolux.
| Device ID | K123257 |
| 510k Number | K123257 |
| Device Name: | EMVERA DIOLUX |
| Classification | Powered Laser Surgical Instrument |
| Applicant | EMVERA TECHNOLOGIES, INC. 1468 HARWELL AVE. Crofton, MD 21114 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-10-18 |
| Decision Date | 2012-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863267000318 | K123257 | 000 |
| 00863267000301 | K123257 | 000 |