FDA applicant

Intl. Solarium Manufacturer, Inc.

North Hollywood, CA3 decisions1985–19850 recalls

FDA records 3 decisions for Intl. Solarium Manufacturer, Inc. (North Hollywood, CA) in 1985: 3 510(k) clearances. Most are in product codes FTC (Light, Ultraviolet, Dermatological) and 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 Intl. Solarium Manufacturer, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Intl. Solarium Manufacturer, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Intl. Solarium Manufacturer, Inc.’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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Intl. Solarium Manufacturer, Inc.

Which product codes does it file in?

What has FDA decided for it lately?