510(k) Report

Devices descending from K181218

7 later devices reach AlignRT Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193431AlignRT PlusVision Rt, Ltd.20206—
+2K203387AlignRT PlusVision Rt, Ltd.20215—
+3K212583AlignRT PlusVision Rt, Ltd.20214—
+4K233622AlignRT PlusVision Rt, Ltd.20242—
+4K232031LUNA 3DLap GmbH Laser Applikationen20240—
+5K253004LUNA 3DLap GmbH Laser Applikationen20260—
+5K253012AlignRT Plus (8.0)Vision Rt, Ltd.20260—