THOR Photomedicine Ltd

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2419-2025Class IIBrand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software VersJuly 24, 2025
Z-2418-2025Class IIBrand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software VersJuly 24, 2025
Z-2416-2025Class IIBrand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A ProducJuly 24, 2025
Z-2417-2025Class IIBrand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A ProJuly 24, 2025
Z-0972-2024Class IINovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - RegNovember 20, 2023
Z-0455-2024Class IINovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183September 13, 2022
Z-0453-2024Class IINovoTHOR Gen 2.0 whole body red light therapy bed, model S1176September 13, 2022
Z-0454-2024Class IIG041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177September 13, 2022
Z-0456-2024Class IINovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184.September 13, 2022