510(k) Report

Devices descending from K080612

9 later devices reach Leica FL800 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170239Leica FL560Leica Microsystems (Schweiz) AG20170—
+1K141136Leica FL800Leica Biosystems Richmond20143—
+1K100468Zeiss Infrared 800 with Flow 800 OptionCarl Zeiss Surgical GmbH20104—
+2K231986Modus IRSynaptive Medical, Inc.20240—
+2K231075Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)Carl Zeiss Meditec, Inc.20230—
+2K202391DIR 800Aesculap, Inc.20211—
+2K190772SURGICAL MICROSCOPE SYSTEM ORBEYE with IROlympus Medical Systems Corp.20190—
+2K181537GLOW800Leica Microsystems (Schweiz) AG20180—
+3K243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)20250—