510(k) Report

FDA applicant

Chromogenex Technologies Limited

Llanelli, Carmarthenshire, GB3 decisions2008–20120 recalls

FDA records 3 decisions for Chromogenex Technologies Limited (Llanelli, Carmarthenshire, GB) from 2008 to 2012: 3 510(k) clearances. Most are in product codes NUV (Massager, Vacuum, Light Induced Heating) and OLI (Fat Reducing Low Level Laser). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Chromogenex Technologies, Ltd.”.

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 Chromogenex Technologies Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2008: 12010: 12012: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Chromogenex Technologies Limited by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Chromogenex”

FDA records each applicant name separately; these may or may not be the same firm.