The following data is part of a premarket notification filed by El.en. Electronic Engineering Spa with the FDA for Derma Yag.
| Device ID | K062762 |
| 510k Number | K062762 |
| Device Name: | DERMA YAG |
| Classification | Powered Laser Surgical Instrument |
| Applicant | EL.EN. ELECTRONIC ENGINEERING SPA 17 VIA BALDANZESE Calenzano, IT 50041 |
| Contact | Andrea Tozzi |
| Correspondent | Andrea Tozzi EL.EN. ELECTRONIC ENGINEERING SPA 17 VIA BALDANZESE Calenzano, IT 50041 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-15 |
| Decision Date | 2007-03-01 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DERMA YAG 78948815 not registered Dead/Abandoned |
DermaMed International, Inc. 2006-08-09 |