Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K212891 |
Device Name |
TempSure System |
Applicant |
Cynosure, LLC |
5 Carlisle Road |
Westford,
MA
01886
|
|
Applicant Contact |
Michael King |
Correspondent |
Cynosure, LLC |
5 Carlisle Road |
Westford,
MA
01886
|
|
Correspondent Contact |
Michael King |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/10/2021 |
Decision Date | 03/18/2022 |
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
|
|
|