Device Classification Name |
light, ultraviolet, dermatological
|
510(k) Number |
K050080 |
Device Name |
CYNOSUREA ECLILITE AND ECLILITE U |
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 | 878.4630
|
Classification Product Code |
|
Date Received | 01/13/2005 |
Decision Date | 05/05/2005 |
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
|