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Hironic Co., Ltd.

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories3
Latest FDA decision2026-04-06
TypeNumberDevice NameCodeDateActions
510(k) K260397 SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)GEI2026-04-06 View
510(k) K251334 NEW DOUBLO 2.0GEI2025-09-29 View
510(k) K241099 Plasonic (Plasonic)GEI2024-11-08 View
510(k) K233123 SILKROGEI2024-06-24 View
510(k) K210084 SILKROGEI2022-06-03 View
510(k) K201773 PICOHIGEX2021-10-19 View
510(k) K192970 SLIMUSPKT2020-12-01 View
510(k) K173676 A-FITGEX2018-09-14 View