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 | K150516 |
| 510k Number | K150516 |
| Device Name: | DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | EL.EN ELECTRONIC ENGINEERING SPA VIA BALDANZESE 17 Calenzano, IT 50041 |
| Contact | Paolo Peruzzi |
| Correspondent | Paolo Peruzzi EL.EN ELECTRONIC ENGINEERING SPA VIA BALDANZESE 17 Calenzano, IT 50041 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-02 |
| Decision Date | 2015-04-13 |
| Summary: | summary |