Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K100384 |
FOIA Releasable 510(k) |
K100384
|
Device Name |
FIBERLASE C02 LASER WAVEGUIDE |
Applicant |
LUMENIS, LTD. |
20 HATAAS STR (POB 124) |
KFAR SABA,
IL
44425
|
|
Applicant Contact |
AHAVA STEIN |
Correspondent |
LUMENIS, LTD. |
20 HATAAS STR (POB 124) |
KFAR SABA,
IL
44425
|
|
Correspondent Contact |
AHAVA STEIN |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 02/16/2010 |
Decision Date | 04/12/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|