Device Classification Name |
Light Based Over-The-Counter Hair Removal
|
510(k) Number |
K222598 |
Device Name |
IPL Hair Removal Device |
Applicant |
Shenzhen Noble Smart Manufacturing Tech Co. Ltd |
3F, Building A, Zhengchangda Technology Park, |
Jian'an, Fuhai Town, Bao'an District |
Shenzhen,
CN
518103
|
|
Applicant Contact |
Guo Yi |
Correspondent |
Shenzhen Reanny Medical Devices Management Consulting Co Ltd |
Room 1407, Jingting Building, Dongzhou Community, |
Guangming Street, Guangming District |
Shenzhen,
CN
518000
|
|
Correspondent Contact |
Reanny Wang |
Regulation Number | 878.4810
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/29/2022 |
Decision Date | 11/17/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|