510(k) Report

FDA applicant

Home Well Trading, Ltd.

Tortola, VG2 decisions2018–20180 recalls

FDA records 2 decisions for Home Well Trading, Ltd. (Tortola, VG) in 2018: 2 510(k) clearances. All are in product code OHT (Light Based Over-The-Counter Hair Removal). Its devices cite 5 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, general and plastic surgery panel, where it files most

How often FDA has decided Home Well Trading, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2018

2018: 2
2018high 2 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Home Well Trading, Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Home Well Trading, 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?

  • OHTLight Based Over-The-Counter Hair Removal2decisions

Whose devices does it build on?

Its devices cite 5 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.

  • K181734Beurer IPL 8500 device/ IPL VelvetSkin ProHome Well Trading, Ltd. · 20181cites it

What has FDA decided for it lately?

  • K181734Beurer IPL 8500 device/ IPL VelvetSkin ProHome Well Trading, Ltd. · 2018
  • K181121Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin ProHome Well Trading, Ltd. · 2018

All 2 as Home Well Trading, Ltd. →