Device Classification Name |
Laser, Comb, Hair
|
510(k) Number |
K213025 |
Device Name |
Laser hair growth helmet |
Applicant |
Kam Yuen Plastic Products Ltd. |
No. 2, Hengfeng 2nd Road, Pujin Industrial, Konghou Town |
Zhongshan,
CN
528400
|
|
Applicant Contact |
Anna Dan |
Correspondent |
Guangdong Jianda Medical Technology Co Ltd |
906 Room, Longxiang Garden, Tianhe District |
Guangzhou,
CN
|
|
Correspondent Contact |
Jett Lee |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 09/21/2021 |
Decision Date | 05/12/2022 |
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
|
|
|