Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K140719 |
Device Name |
PICOSURE WORKSTATION |
Applicant |
CYNOSURE, INC. |
5 CALISLE ROAD |
WESTFORD,
MA
01886
|
|
Applicant Contact |
KEVIN O'CONNELL |
Correspondent |
CYNOSURE, INC. |
5 CALISLE ROAD |
WESTFORD,
MA
01886
|
|
Correspondent Contact |
KEVIN O'CONNELL |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 03/21/2014 |
Decision Date | 09/22/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02091089 NCT02091102
|
Reviewed by Third Party |
No
|
Combination Product |
No
|