510(k) Report

Devices descending from K012096

6 later devices reach Disposable Vitrectomy Lens through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173944Endocular Viewing Lenses and Silicone RingPhakos20180—
+1K142715Sensor Medical Family of Vitrectomy Lenses and ProductsSensor Medical Technology, LLC20141—
+1K051630Super View Disposable Biom Lens SetInsight Instruments, Inc.20050—
+1K050623Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism…Volk Optical, Inc.200521
+1K033950Dorc Vitrectomy Lenses, Model 1284 SeriesDutch Ophthalmic Research Center (D.O.R.C.)20040—
+2K151961Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensVolk Optical, Inc.20151—