The following data is part of a premarket notification filed by Lumenis Ltd. with the FDA for Fiberlase Endure Co2 Fiber.
| Device ID | K130164 |
| 510k Number | K130164 |
| Device Name: | FIBERLASE ENDURE CO2 FIBER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS LTD. 31 HAAVODA ST. Binyamina, IL 30500 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy LUMENIS LTD. 31 HAAVODA ST. Binyamina, IL 30500 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-23 |
| Decision Date | 2013-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109143002 | K130164 | 000 |
| 07290109142999 | K130164 | 000 |
| 07290109142982 | K130164 | 000 |
| 07290109142081 | K130164 | 000 |