510(k) Report

FDA applicant

Wingderm Electro-Optics, Ltd.

Beijing, CN3 decisions2019–20262 recalls

FDA records 3 decisions for Wingderm Electro-Optics, Ltd. (Beijing, CN) from 2019 to 2026: 3 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and ONG (Powered Laser Surgical Instrument With…). Its devices cite 8 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Wingderm Electro-Optics, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2019: 12020: 12026 (partial year): 1
2019high 1 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

2in 2024

2024: 2
2019high 2 (2024) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Wingderm Electro-Optics, Ltd. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Wingderm Electro-Optics, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument2decisions
  • ONGPowered Laser Surgical Instrument With MicrobeamFractional Output1decision

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd. · 20201cites it

What has FDA decided for it lately?

  • K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd. · 2026
  • K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd. · 20201 recall
  • K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd. · 20191 recall

All 3 as Wingderm Electro-Optics, Ltd. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K191611Diode Laser Hair Removal model: WLA-01Aug 23, 2024Class II
  • K192350Non-ablative Fractional Laser Systems, Model: WFB-01Aug 23, 2024Class II