Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K171262 |
Device Name |
TempSure |
Applicant |
Cynosure, Inc |
5 Carlisle Road |
westford,
MA
01886
|
|
Applicant Contact |
amy tannenbaum |
Correspondent |
Cynosure, Inc |
5 Carlisle Road |
westford,
MA
01886
|
|
Correspondent Contact |
amy tannenbaum |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/01/2017 |
Decision Date | 09/22/2017 |
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
|
|
|