510(k) Report

Devices descending from K960475

403 later devices reach Modified Luxar LX-20 Family CO2 Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K242349FoLixLumenis Be, Ltd.20240—
+11K240780InMode RF SystemInMode, Ltd.20243—
+12K243737Inbella RF SystemInbella Medical, Inc.20250—