Data / Medical devices / China / Shenzhen Fansizhe Science And Technology Co., Ltd.
Shenzhen Fansizhe Science And Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 5 510(k) clearances
Shenzhen Fansizhe Science And Technology Co., Ltd. is registered with the FDA (registration 3023281259) in Shenzhen Guangdong, China. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 29, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023281259
- Address
- 2nd, 3rd And 4th floors, No.11, Henggangxia Industrial Zone Xiangshan Community, Xinqiao Street, Bao'an District, Shenzhen Guangdong, China, 518125
- Owner or operator
- Shenzhen Fansizhe Science And Technology Co., Ltd. (10085107)
- Roles
- Manufacturer
- First device listed
- May 5, 2022
- Registered through
- 2026
- Brand names listed
- Intense Pulsed Light (IPL) System (Models: T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF), Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH), Intense Pulsed Light (IPL) System (Models: T505KQ, T505KH, T505KF, SL-B505WM), Intense Pulsed Light (IPL) System, Model: T003AW, T010AW, Intense Pulsed Light (IPL) System, Model: T012C, Intense Pulsed Light (IPL) System, Model: T013C, T015C, T015K, T015A, Intense Pulsed Light (IPL) System, Model: T050AW, Intense Pulsed Light (IPL) System, Model: T053K, T055K, T056K, T026K, T035K and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light Based Over-The-Counter Hair Removal | OHT | 2 | Manufacturer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 29, 2025 | K253881 | Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) | OHT | Substantially Equivalent | Shenzhen Fansizhe Science and Technology Co., Ltd. | accessdata.fda.gov |
| July 14, 2025 | K251173 | Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF) | OHT | Substantially Equivalent | Shenzhen Fansizhe Science and Technology Co., Ltd. | accessdata.fda.gov |
| March 28, 2023 | K223928 | Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K | OHT | Substantially Equivalent | Shenzhen Fansizhe Science and Technology Co., Ltd. | accessdata.fda.gov |
| June 30, 2022 | K221569 | Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K | OHT | Substantially Equivalent | Shenzhen Fansizhe Science and Technology Co., Ltd. | accessdata.fda.gov |
| April 11, 2022 | K212881 | Intense Pulsed Light (IPL) System | OHT | Substantially Equivalent | Shenzhen Fansizhe Science and Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Light Based Over-The-Counter Hair Removal
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Updated December 29, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.