Wingderm Electro-Optics Ltd.
Beijing, CN
WINGDERM ELECTRO-OPTICS LTD. appears in FDA device records in Beijing, CN. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Wingderm Electro-Optics Ltd. between 2019 and 2026. The busiest year on record is 2019, with 1. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2020 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252599 | Diode Laser Therapy Systems (WLA-02) | GEX | Substantially Equivalent | |
| K192350 | Medical Non-Ablative Fractional Laser Systems | ONG | Substantially Equivalent | |
| K191611 | Diode Laser Therapy Systems | GEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014310779 | 3014310779 | WINGDERM ELECTRO-OPTICS LTD. | Building 6, No.97 Changping Road, Changping District, Beijing 102206 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0556-2025 | Diode Laser Hair Removal model: WLA-01 | All model WLA-01 systems sold to US customers are found to have labeling non-compliances | Class II | Open, Classified | |
| Z-0555-2025 | 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) | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain