510(k) Report

FDA applicant

Endymion Medical, Ltd.

Binyamina, IL2 decisions2009–20130 recalls

FDA records 2 decisions for Endymion Medical, Ltd. (Binyamina, IL) from 2009 to 2013: 2 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 6 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 Endymion Medical, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2009: 12013: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Endymion Medical, Ltd. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 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.

  • K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd. · 200912cite it

What has FDA decided for it lately?

  • K130793Newa Skin Therapy SystemEndymion Medical, Ltd. · 2013
  • K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd. · 2009

All 2 as Endymion Medical, Ltd. →