Device Classification Name |
stimulator, transcutaneous electrical, aesthetic purposes
|
510(k) Number |
K171821 |
Device Name |
2 Face / Face Evolution |
Applicant |
Heat In A Click |
1975 Tigertail Blvd Dania |
Homestead,
FL
33034
|
|
Applicant Contact |
Guy Levi |
Correspondent |
Guangzhou GLOMED Biological Technology Co., Ltd. |
Suite 306, Kecheng Mansion, No.121 Science Road |
Guangzhou Science Park |
Guangzhou,
CN
510006
|
|
Correspondent Contact |
Cassie Lee |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/19/2017 |
Decision Date | 04/26/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|