510(k) Report

FDA applicant

Free Sun Intl. AB

Reseda, CA1 decision1988–19880 recalls

FDA records 1 decision for Free Sun Intl. AB (Reseda, CA) in 1988: 1 510(k) clearance. All are in product code HOY (Shield, Eye, Ophthalmic (Including Sunlamp…). 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, ophthalmic panel, where it files most

How often FDA has decided Free Sun Intl. AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Free Sun Intl. AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Free”

FDA records each applicant name separately; these may or may not be the same firm.