510(k) Report

Devices descending from K170718

3 later devices reach Iridex TruFocus LIO Premiere through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201623LION PhotocoagulatorNorlase Aps20201—
+1K181662Iridex TruFocus LIO PremiereIridex Corporation20180—
+2K251507Integre LioQuantel Medical20260—