Device Classification Name |
laser, comb, hair
|
510(k) Number |
K210169 |
Device Name |
Hair Growth Device |
Applicant |
Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd |
401, Building 1, #3, Xinxing 3rd Road, jiaoshe, Dongkeng |
Town |
Dongguan,
CN
523586
|
|
Applicant Contact |
Liu Jianwen |
Correspondent |
Guangzhou Junyi Information Technology Co., Ltd. |
Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town |
Huangpu District, Guangzhou City,
CN
510663
|
|
Correspondent Contact |
Jinghua Zhou |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 01/22/2021 |
Decision Date | 04/16/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|