510(k) Report

FDA applicant

California Suncare, Inc.

Los Angeles, CA1 decision1991–19910 recalls

FDA records 1 decision for California Suncare, Inc. (Los Angeles, CA) in 1991: 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 California Suncare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for California Suncare, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like California Suncare, 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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