Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K143105 |
Device Name |
Picosure Workstation |
Applicant |
CYNOSURE, INC. |
5 CARLISLE ROAD |
WESTFORD,
MA
01886
|
|
Applicant Contact |
Kelli McMillan |
Correspondent |
CYNOSURE, INC. |
5 CARLISLE ROAD |
WESTFORD,
MA
01886
|
|
Correspondent Contact |
Kelli McMillan |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 10/29/2014 |
Decision Date | 02/23/2015 |
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
|