510(k) Report

Devices descending from K954169

3 later devices reach Hanaulux Blue 30 & 80 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113679Lucea Led Surgical Light SystemMaquet S.A.S.201221
+2K140812MI-750 Procedural/Minor Surgical LightMedical Illumination International, Inc.20140—
+2K130513Volista 400; Volista 600Maquet S.A.S.2013019