Device Classification Name |
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
|
510(k) Number |
K123435 |
Device Name |
IPL THERAPY SYSTEM |
Applicant |
BEIJING SINCOHEREN S&T DEVELOPMENT CO LTD |
7TH FLOOR 982 CONGYUN ROAD, BAIYUN DISTRICT |
GUANGZHOU, GUANGDONG,
CN
510420
|
|
Applicant Contact |
MIKE GU |
Correspondent |
BEIJING SINCOHEREN S&T DEVELOPMENT CO LTD |
7TH FLOOR 982 CONGYUN ROAD, BAIYUN DISTRICT |
GUANGZHOU, GUANGDONG,
CN
510420
|
|
Correspondent Contact |
MIKE GU |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 11/07/2012 |
Decision Date | 02/11/2013 |
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
|
|
|