510(k) Report

Devices descending from DEN180024

4 later devices reach Leica FL400 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232567Myriad SPECTRA Light SourceNico Corporation202401
+1K211346BLUE 400Carl Zeiss Meditec, AG20222—
+2K251286Affirm 400Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)20260—
+2K240215Blue 400; Blue 400 SCarl Zeiss Meditec, AG20240—