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 |