The following data is part of a premarket notification filed by Espansione Marketing S.p.a with the FDA for E-light Line.
| Device ID | K092734 |
| 510k Number | K092734 |
| Device Name: | E-LIGHT LINE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ESPANSIONE MARKETING S.P.A VIA BORGO SANTA CRISTINA, 12 Imola, Bologna, IT 40026 |
| Contact | Guido Bonapace |
| Correspondent | Guido Bonapace ESPANSIONE MARKETING S.P.A VIA BORGO SANTA CRISTINA, 12 Imola, Bologna, IT 40026 |
| Product Code | GEX |
| Subsequent Product Code | ISA |
| Subsequent Product Code | OAP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-04 |
| Decision Date | 2010-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056389700217 | K092734 | 000 |
| 08056389701368 | K092734 | 000 |
| 08056389701375 | K092734 | 000 |
| 08056389701412 | K092734 | 000 |
| 08056389700712 | K092734 | 000 |
| 08056389700446 | K092734 | 000 |
| 08056389700453 | K092734 | 000 |
| 08056389700415 | K092734 | 000 |
| 08056389700422 | K092734 | 000 |
| 08056389701351 | K092734 | 000 |