The following data is part of a premarket notification filed by Shenzhen Fansizhe Science And Technology Co., Ltd with the FDA for Intense Pulsed Light (ipl) System, Model: T013c, T015c, T015k.
| Device ID | K221569 |
| 510k Number | K221569 |
| Device Name: | Intense Pulsed Light (IPL) System, Model: T013C, T015C, T015K |
| Classification | Light Based Over-the-counter Hair Removal |
| 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 |
| Contact | Endang Cheng |
| Correspondent | You Yijie Qimmiq Medical Consulting Service Co., Ltd. RM.406, Building C, Run Science Park, No.18 Shenzhou Road, Huangpu Guangzhou, CN 510663 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-31 |
| Decision Date | 2022-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971008271065 | K221569 | 000 |
| 06971008271058 | K221569 | 000 |
| 06971008271041 | K221569 | 000 |
| 06971008271072 | K221569 | 000 |