The following data is part of a premarket notification filed by El.en. Electronic Engineering Spa with the FDA for Deka Synchro Repla: Y Family Of Laser Systems.
| Device ID | K131095 |
| 510k Number | K131095 |
| Device Name: | DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | EL.EN. ELECTRONIC ENGINEERING SPA 17 VIA BALDANZESE Calenzano, IT 50041 |
| Contact | Paolo Peruzzi |
| Correspondent | Paolo Peruzzi 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 | 2013-04-18 |
| Decision Date | 2013-12-05 |
| Summary: | summary |