The following data is part of a premarket notification filed by Lumenis, Ltd. with the FDA for Fiberlase C02 Laser Waveguide.
| Device ID | K100384 |
| 510k Number | K100384 |
| Device Name: | FIBERLASE C02 LASER WAVEGUIDE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS, LTD. 20 HATAAS STR (POB 124) Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein LUMENIS, LTD. 20 HATAAS STR (POB 124) Kfar Saba, IL 44425 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-04-12 |
| Summary: | summary |