Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K140388 |
Device Name |
LUMENIS PULSE 120H |
Applicant |
LUMENIS LTD. |
155 BIALIK STREET |
RAMAT GAN,
IL
5252346
|
|
Applicant Contact |
MERAV YARMUS |
Correspondent |
LUMENIS LTD. |
155 BIALIK STREET |
RAMAT GAN,
IL
5252346
|
|
Correspondent Contact |
MERAV YARMUS |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 02/14/2014 |
Decision Date | 03/14/2014 |
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
|