The following data is part of a premarket notification filed by Dermeo with the FDA for Mediflash And Esteflash.
| Device ID | K093168 |
| 510k Number | K093168 |
| Device Name: | MEDIFLASH AND ESTEFLASH |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | DERMEO 1468 Harwell Avenue Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith DERMEO 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-07 |
| Decision Date | 2010-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00686209171125 | K093168 | 000 |
| 00686209171026 | K093168 | 000 |