The following data is part of a premarket notification filed by El.en Electronic Engineering Spa with the FDA for Deka Lipoai.
| Device ID | K212270 |
| 510k Number | K212270 |
| Device Name: | DEKA LipoAI |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-20 |
| Decision Date | 2021-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08057017760580 | K212270 | 000 |