510(k) Report

Devices descending from K171648

2 later devices reach BM.Iris through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+1K212082PicoreBio-Med USA, Inc.20210—