The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for El Lightwave Suction Ablator, Model El-2000-s, Lightwave Suction Ablator, Model Ia-2000-s, Lightwave Ablator, Model Ia-.
| Device ID | K083281 |
| 510k Number | K083281 |
| Device Name: | EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA- |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Lisa Anderson |
| Correspondent | Lisa Anderson LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-07 |
| Decision Date | 2009-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854040369 | K083281 | 000 |
| 20845854040352 | K083281 | 000 |
| 20845854040345 | K083281 | 000 |
| 10653405059738 | K083281 | 000 |
| 20653405059735 | K083281 | 000 |
| 10845854040348 | K083281 | 000 |