510(k) Report

Devices descending from K843646

5 later devices reach Steinway Micro-Kerato-Trephine through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981155Flapmaker Disposable MicrokeratomeHawken Industries19984—
+2K052891Horizon Epikeratome Disposable Microkeratome SystemHawken Industries20060—
+2K990900Microkeratome, Model MK-2000Nidek, Inc.19992—
+3K032297Disposable N-PE Mickrokeratome BladesOasis Medical, Inc.20030—
+3K022205Disposable N-PE Microkeratome BladesOasis Medical, Inc.20020—