Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K083733 |
Device Name |
LUME 2 SYSTEM, MODEL GA0005000 |
Applicant |
LUMENIS, LTD. |
3959 WEST 1820 SOUTH |
SALT LAKE CITY,
UT
84104
|
|
Applicant Contact |
FRANCES HARRISON |
Correspondent |
LUMENIS, LTD. |
3959 WEST 1820 SOUTH |
SALT LAKE CITY,
UT
84104
|
|
Correspondent Contact |
FRANCES HARRISON |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 12/16/2008 |
Decision Date | 05/04/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|