FDA applicant

Theralight, Inc.

Carlsbad, CA4 decisions2002–20060 recalls

FDA records 4 decisions for Theralight, Inc. (Carlsbad, CA) from 2002 to 2006: 4 510(k) clearances. Most are in product codes FTC (Light, Ultraviolet, Dermatological) and GEX (Powered Laser Surgical Instrument). Its devices cite 14 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 Theralight, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Theralight, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Theralight, Inc.

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?