Device Classification Name |
laser for disruption of adipocyte cells for aesthetic use
|
510(k) Number |
K150230 |
Device Name |
SculpSure |
Applicant |
CYNOSURE, INC. |
5 CARLISLE ROAD |
westford,
MA
01886
|
|
Applicant Contact |
kevin o'connell |
Correspondent |
CYNOSURE, INC. |
5 CARLISLE ROAD |
westford,
MA
01886
|
|
Correspondent Contact |
kevin o'connell |
Regulation Number | 878.5400
|
Classification Product Code |
|
Date Received | 02/02/2015 |
Decision Date | 05/15/2015 |
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
|