The following data is part of a premarket notification filed by El.en Electronic Engineering S.p.a. with the FDA for Deka Smartxide Family (smartxide Touch, Smartxide Punto).
| Device ID | K180193 |
| 510k Number | K180193 |
| Device Name: | DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | El.En Electronic Engineering S.p.A. Via Baldanzese 17 Calenzano, IT 50041 |
| Contact | Paolo Peruzzi |
| Correspondent | Paolo Peruzzi El.En Electronic Engineering S.p.A. 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 | 2018-01-24 |
| Decision Date | 2018-02-21 |
| Summary: | summary |