The following data is part of a premarket notification filed by El. En Electronic Engineering Spa with the FDA for Scar 3.
| Device ID | K211362 |
| 510k Number | K211362 |
| Device Name: | SCAR 3 |
| 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 | 2021-05-03 |
| Decision Date | 2021-08-25 |