Medical Device Manufacturer · CN , Shenzhen

Shenzhen Fansizhe Science And Technology Co., Ltd.

5 submissions · 5 cleared · Since 2022

Total

Cleared

Denied

Shenzhen Fansizhe Science And Technology Co., Ltd. — FDA 510(k) Submissions

Shenzhen Fansizhe Science And Technology Co., Ltd. has submitted 5 FDA 510(k) premarket notifications since 2022, of which 5 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Light Based Over-the-counter Hair Removal . Use the specialty filter in the sidebar to narrow results.

5 devices

1–5 of 5

Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)

K253881 · OHT Light Based... · General & Plastic Surgery

Dec 2025 25d

Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)

K251173 · OHT Light Based... · General & Plastic Surgery

Jul 2025 89d

Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K

K223928 · OHT Light Based... · General & Plastic Surgery

Mar 2023 88d

Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K