The following data is part of a premarket notification filed by El.en Electronic Engineering Spa with the FDA for Echolaser X4.
| Device ID | K181510 |
| 510k Number | K181510 |
| Device Name: | ECHOLASER X4 |
| 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 | 2018-06-08 |
| Decision Date | 2018-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08057017760320 | K181510 | 000 |
| 08057017760504 | K181510 | 000 |
| 08057017760559 | K181510 | 000 |