510(k) Report

Devices descending from K121059

4 later devices reach Soleoline, Soleo Stim, Soleo Sono, Soleo Sonostim through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161628JAS Pulse (TM) Ultrasonic TherapyBonutti Research, Inc.20163—
+2K241099Plasonic (Plasonic)Hironic Co., Ltd.20242—
+3K260397SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Hironic Co., Ltd.20260—
+3K251334New Doublo 2.0Hironic Co., Ltd.20250—