510(k) Report

Devices descending from K981155

4 later devices reach Flapmaker Disposable Microkeratome through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052891Horizon Epikeratome Disposable Microkeratome SystemHawken Industries20060—
+1K990900Microkeratome, Model MK-2000Nidek, Inc.19992—
+2K032297Disposable N-PE Mickrokeratome BladesOasis Medical, Inc.20030—
+2K022205Disposable N-PE Microkeratome BladesOasis Medical, Inc.20020—