Device Classification Name |
Laser, Comb, Hair
|
510(k) Number |
K232356 |
Device Name |
Laser Cap, Model: Hat-01 |
Applicant |
Hubei YJT Technology Co.,Ltd |
Room1-4 ,8F,Block7,Guannan Fuxing Pharmaceutical Park,No.62 |
Optical Valley Ave |
Wuhan,
CN
430000
|
|
Applicant Contact |
Jiali Xie |
Correspondent |
Shenzhen Tacro Medical technology services Co., Ltd. |
Suite 405, Bldg. A Nanfeng, No.4093 Liuxian Blvd., Nanshan |
Dist. |
Shenzhen,
CN
510000
|
|
Correspondent Contact |
Gamma Zhang |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 08/07/2023 |
Decision Date | 10/24/2023 |
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
|
|
|