510(k) Report

Devices descending from K974004

9 later devices reach Automated Disposable Keratome (Adk) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990900Microkeratome, Model MK-2000Nidek, Inc.19992—
+1K983317Barron Microkeratome System, Model B2000Barron Precision Instruments, LLC19981—
+1K981742One UP Disposable Keratome HeadMoria, Inc.19983—
+2K040297Oneuse- Plus MicrokeratomeMoria SA20042—
+2K032297Disposable N-PE Mickrokeratome BladesOasis Medical, Inc.20030—
+2K022205Disposable N-PE Microkeratome BladesOasis Medical, Inc.20020—
+2K991124Visijet Hydrokeratome, Model 50Visijet, Inc.20000—
+3K043183EPI-KMoria SA20051—
+4K172994EPI K ConsoleMoria SA20170—