The following data is part of a premarket notification filed by El..en. Electronic Engineering Spa with the FDA for Deka Luxea.
| Device ID | K192539 |
| 510k Number | K192539 |
| Device Name: | Deka Luxea |
| 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 | 2019-09-16 |
| Decision Date | 2019-12-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08057017760429 | K192539 | 000 |
| 08057017760733 | K192539 | 000 |