The following data is part of a premarket notification filed by Lumenis, Ltd. with the FDA for Lume 2 System, Model Ga0005000.
| Device ID | K083733 |
| 510k Number | K083733 |
| Device Name: | LUME 2 SYSTEM, MODEL GA0005000 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS, LTD. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Contact | Frances Harrison |
| Correspondent | Frances Harrison LUMENIS, LTD. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-16 |
| Decision Date | 2009-05-04 |
| Summary: | summary |