510(k) Report

Devices descending from K072912

10 later devices reach Sopro 225 Dual Halogen Light Source through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091829PLS Portable Light SourceOptim, Inc.20099—
+2K133311EndoledOlympus Winter & Ibe GmbH20140—
+2K130503Pathassist Led Light FiberEntellus Medical, Inc.20136—
+2K100125Vision Sciences Flexible Ent ScopeVision-Sciences, Inc.201002
+3K141916Pathassist Led Light FiberEntellus Medical, Inc.20145—
+4K212774VenSure LightGuideIntersect Ent.20221—
+4K152435PassAssist LED Light FiberEntellus Medical, Inc.20152—
+5K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+5K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+5K201398SINUSPRIME Dilation SystemStryker Ent20200—