Data / Medical devices / China / Wingderm Electro-Optics Ltd.
Wingderm Electro-Optics Ltd.: FDA-registered device maker in Beijing, China, 3 510(k) clearances
Wingderm Electro-Optics Ltd. is registered with the FDA (registration 3014310779) in Beijing, China. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 24, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014310779
- Address
- Building 6, No.97 Changping Road, Changping District, Beijing, China, 102206
- Owner or operator
- Wingderm Electro-Optics Ltd. (10061423)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 16, 2019
- Registered through
- 2026
- Brand names listed
- Diode Laser Therapy Systems, Medical Non-ablative Fractional Laser Systems
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| February 24, 2026 | K252599 | Diode Laser Therapy Systems (WLA-02) | GEX | Substantially Equivalent | Wingderm Electro-Optics , Ltd. | accessdata.fda.gov |
| April 30, 2020 | K192350 | Medical Non-Ablative Fractional Laser Systems | ONG | Substantially Equivalent | Wingderm Electro-Optics , Ltd. | accessdata.fda.gov |
| July 31, 2019 | K191611 | Diode Laser Therapy Systems | GEX | Substantially Equivalent | Wingderm Electro-Optics , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 23, 2024 | 95831 | Class II | Ongoing | Non-ablative Fractional Laser Systems, Model: WFB-01 | Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units) | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Powered Laser Surgical Instrument With MicrobeamFractional Output
Updated February 24, 2026. 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.