FDA applicant

Cooltouch Corp.

Roseville, CA6 decisions2000–20060 recalls

FDA records 6 decisions for Cooltouch Corp. (Roseville, CA) from 2000 to 2006: 6 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Cooltouch, Inc.”.

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 Cooltouch Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cooltouch Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Cooltouch Corp.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?