510(k) Report

Devices descending from K150637

11 later devices reach Aerin Medical Wand Model FG011 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161994Aerin Medical StylusAerin Medical, Inc.201610—
+2K162810InSeca ARC Stylus, Aerin ConsoleAerin Medical, Inc.20179—
+3K260255AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)Aventix Medical, Inc.20260—
+3K242630Aerin ConsoleAerin Medical, Inc.20240—
+3K192471RHIN1 StylusAerin Medical, Inc.20194—
+3K172529Vivaer ARC StylusAerin Medical, Inc.20171—
+4K212666Neuromark SystemNeurent Medical20213—
+4K200300VivAer StylusAerin Medical, Inc.202001
+5K222032NEUROMARK SystemNeurent Medical20222—
+6K250048NEUROMARK System (NMK00301)Neurent Medical, Ltd.20251—
+7K261833NEUROMARK System (NMK00301)Neurent Medical, Ltd.20260—