Company ยท CN
Shenzhen Fansizhe Science and Technology Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2022 to 2025. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OHT | Light Based Over-The-Counter Hair Removal | 5 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 29, 2025 | K253881 | Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505K Shenzhen Fansizhe Science and Technology Co., Ltd., CN | OHT |
| Jul 14, 2025 | K251173 | Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002A Shenzhen Fansizhe Science and Technology Co., Ltd., CN | OHT |
| Mar 28, 2023 | K223928 | Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T Shenzhen Fansizhe Science and Technology Co., Ltd., CN | OHT |
| Jun 30, 2022 | K221569 | Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K Shenzhen Fansizhe Science and Technology Co., Ltd., CN | OHT |
| Apr 11, 2022 | K212881 | Intense Pulsed Light (IPL) System Shenzhen Fansizhe Science and Technology Co., Ltd., CN | OHT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||