Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K031125 |
Device Name |
CYNOSURE SMART FILE ND:YAG LASERS |
Applicant |
CYNOSURE, INC. |
10 ELIZABETH DR. |
CHELMSFORD,
MA
01824
|
|
Applicant Contact |
GEORGE CHO |
Correspondent |
CYNOSURE, INC. |
10 ELIZABETH DR. |
CHELMSFORD,
MA
01824
|
|
Correspondent Contact |
GEORGE CHO |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 04/09/2003 |
Decision Date | 10/09/2003 |
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
|