The following data is part of a premarket notification filed by Elen Electronic Engineering Spa with the FDA for Deka Motus Ay.
| Device ID | K181486 |
| 510k Number | K181486 |
| Device Name: | DEKA Motus AY |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Elen Electronic Engineering Spa Via Baldanzese, 17 Calenzano, IT 50041 |
| Contact | Paolo Peruzzi |
| Correspondent | Paolo Peruzzi Elen Electronic Engineering Spa Via Baldanzese, 17 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 | 2018-06-06 |
| Decision Date | 2018-08-30 |
| Summary: | summary |