510(k) Report

Devices descending from K161628

3 later devices reach JAS Pulse (TM) Ultrasonic Therapy through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241099Plasonic (Plasonic)Hironic Co., Ltd.20242—
+2K260397SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Hironic Co., Ltd.20260—
+2K251334New Doublo 2.0Hironic Co., Ltd.20250—