Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K130164 |
FOIA Releasable 510(k) |
K130164
|
Device Name |
FIBERLASE ENDURE CO2 FIBER |
Applicant |
LUMENIS LTD. |
31 HAAVODA ST. |
BINYAMINA,
IL
30500
|
|
Applicant Contact |
YORAM LEVY |
Correspondent |
LUMENIS LTD. |
31 HAAVODA ST. |
BINYAMINA,
IL
30500
|
|
Correspondent Contact |
YORAM LEVY |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 01/23/2013 |
Decision Date | 03/24/2013 |
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
|