510(k) Report

FDA applicant

Raja Trading Company, Inc.

Fairfax, VA3 decisions2020–20250 recalls

FDA records 3 decisions for Raja Trading Company, Inc. (Fairfax, VA) from 2020 to 2025: 3 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and NFO (Stimulator, Transcutaneous Electrical…). Since 2016 its 510(k)s took a median of 139 days from receipt to decision, against 123 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 1 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, general and plastic surgery panel, where it files most

How often FDA has decided Raja Trading Company, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2020: 12021: 12025: 1
2020high 1 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Raja Trading Company, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument2decisions
  • NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 139 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 123 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K200104OxylightRaja Trading Company, Inc. · 20205cite it
  • K202175OxyLight 2.0Raja Trading Company, Inc. · 20211cites it

What has FDA decided for it lately?

  • K243063Myolight Microcurrent HandpieceRaja Trading Company, Inc. · 2025
  • K202175OxyLight 2.0Raja Trading Company, Inc. · 2021
  • K200104OxylightRaja Trading Company, Inc. · 2020

All 3 as Raja Trading Company, Inc. →