Device Classification Name |
Light Based Over-The-Counter Hair Removal
|
510(k) Number |
K221569 |
Device Name |
Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K |
Applicant |
Shenzhen Fansizhe Science And Technology Co., Ltd |
2nd and 3rd floors, No. 17, Xinfa 2nd Road, Xinqiao |
Community, Xinqiao Street, Baoan District |
Shenzhen,
CN
518125
|
|
Applicant Contact |
Endang Cheng |
Correspondent |
Qimmiq Medical Consulting Service Co., Ltd. |
RM.406, Building C, Run Science Park, |
No.18 Shenzhou Road, Huangpu |
Guangzhou,
CN
510663
|
|
Correspondent Contact |
You Yijie |
Regulation Number | 878.4810
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/31/2022 |
Decision Date | 06/30/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|