FDA applicant
Shanghai Sigma High-Tech Co., Ltd.
FDA records 1 decision for Shanghai Sigma High-Tech Co., Ltd. (Shanghai, CN) in 2024: 1 510(k) clearance. All are in product code FTC (Light, Ultraviolet, Dermatological). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Shanghai Sigma High-Tech Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Shanghai Sigma High-Tech Co., Ltd.’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