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FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories4
Latest FDA decision2026-04-10
TypeNumberDevice NameCodeDateActions
510(k) K253926 DiacoreNGX2026-04-10 View
510(k) K251649 Sunny Plus (Sunny)NFO2025-09-18 View
510(k) K242241 SunnyGEI2025-03-19 View
510(k) K241535 Vybe RF IIGEI2024-09-25 View
510(k) K232223 PlaDuo SystemGEI2023-10-24 View
510(k) K230968 VYBE RF Electrosurgical SystemGEI2023-07-06 View
510(k) K221363 AF LaserPDZ2022-07-20 View
510(k) K211562 Virtue RFGEI2021-11-23 View
510(k) K193070 VIVACE Electrosurgical DeviceGEI2021-04-26 View
510(k) K202415 VirtueRFGEI2021-01-22 View
510(k) K201735 PlaDuo SystemGEI2020-12-14 View
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