510(k) Report

FDA applicant

Curelight, Ltd.

Washington, DC6 decisions2002–20040 recalls

FDA records 6 decisions for Curelight, Ltd. (Washington, DC) from 2002 to 2004: 6 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 4 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 Curelight, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Curelight, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Curelight, 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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