510(k) Report

FDA applicant

Uniphy Elektromedizin GmbH & Co. KG

Bilzen, BE1 decision2006–20060 recalls

FDA records 1 decision for Uniphy Elektromedizin GmbH & Co. KG (Bilzen, BE) in 2006: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 1 predicate, 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 Uniphy Elektromedizin GmbH & Co. KG’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Uniphy Elektromedizin GmbH & Co. KG since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Uniphy Elektromedizin GmbH & Co. KG by year, 2007–2026Sources: 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 Instrument1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K052310Cryoflow 700, Cryoflow 1000Uniphy Elektromedizin GmbH & Co. KG · 2006

The one decision as Uniphy Elektromedizin GmbH & Co. KG →