Device Classification Name |
Laser, Comb, Hair
|
510(k) Number |
K213447 |
Device Name |
LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210. |
Applicant |
Shenzhen CosBeauty Technology Co., Ltd. |
UnitA-3F, Qiao De Industrial Park, |
Tian Liao Guang Ming District |
Shenzhen,
CN
518000
|
|
Applicant Contact |
Ares Zou |
Correspondent |
Feiying Drug & Medical Consulting Technical Service Group |
Rm 2401 Zhenye International Business Center, No. 3101-90 |
Qianhai Road, |
Shenzhen,
CN
518052
|
|
Correspondent Contact |
Tracy Che |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 10/25/2021 |
Decision Date | 01/19/2022 |
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
|
|
|