510(k) Report

FDA applicant

Li-Tek Electronic Technology Corporation

Dongguan, CN3 decisions2017–20170 recalls

FDA records 3 decisions for Li-Tek Electronic Technology Corporation (Dongguan, CN) in 2017: 3 510(k) clearances. Most are in product codes NFO (Stimulator, Transcutaneous Electrical…) and OLP (Over-The-Counter Powered Light Based Laser For…). Since 2016 its 510(k)s took a median of 189 days from receipt to decision, against 189 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Li-Tek Electronic Technology Corporation’s devices, and how often a recall has named them.

FDA decisions per year

3in 2017

2017: 3
2017high 3 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Li-Tek Electronic Technology Corporation by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Li-Tek Electronic Technology Corporation’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?

  • NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes2decisions
  • OLPOver-The-Counter Powered Light Based Laser For Acne1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 189 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 189 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 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.

  • K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 20175cite it
  • K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation · 20172cite it

What has FDA decided for it lately?

  • K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation · 2017
  • K162106Micro-current Wrinkle Reduction Facial service, model EP-400Li-Tek Electronic Technology Corporation · 2017
  • K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017

All 3 as Li-Tek Electronic Technology Corporation →