FDA applicant
Sun Shanty, Inc.
FDA records 4 decisions for Sun Shanty, Inc. (Walker, MI) from 1980 to 1984: 4 510(k) clearances. All are in product code FTC (Light, Ultraviolet, Dermatological). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Sun Shanty, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Sun Shanty, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Sun Shanty, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report