510(k) Report

FDA applicant

Coolanalgesia, Ltd.

Cambridge, England, GB1 decision2004–20040 recalls

FDA records 1 decision for Coolanalgesia, Ltd. (Cambridge, England, GB) in 2004: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). 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 Coolanalgesia, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Coolanalgesia, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Coolanalgesia, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Coolanalgesia, 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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