FDA applicant

Sunfit, Inc.

New Rochelle, NY3 decisions1980–19860 recalls

FDA records 3 decisions for Sunfit, Inc. (New Rochelle, NY) from 1980 to 1986: 3 510(k) clearances. Most are in product codes FTC (Light, Ultraviolet, Dermatological) and LEJ (Booth, Sun Tan). 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 Sunfit, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sunfit, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Sunfit, Inc.

Which product codes does it file in?

What has FDA decided for it lately?