510(k) Report

Devices descending from K973064

30 later devices reach Keeler Tearscope-Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092374Ois Eyescan Portable Modular Imaging System, Model Ois EyescanOphthalmic Imaging Systems200922—
+1K091935Lipiview Ocular Surface InterferometerTearscience, Inc.20096—
+2K190573KOWA DR-1aKowa Company, Ltd.20190—
+2K152869LipiView II Ocular Surface InterferometerTearscience, Inc.20161—
+2K122481Lipiview Ocular Surface InterferometerTearscience, Inc.20122—
+2K111771Non-Contact Tear Film ThermograghUnited Integrated Services Co., Ltd.20111—
+2K101935Centervue Digital Retinography SystemCentervue S.P.A.201021—
+3K253176TearViewBeyond 700 Pty, Ltd.20260—
+3K202221VX650Luneau Technology Operations20210—
+3K190954Fundus CameraChongqing Bio Newvision Medical Equipment, Ltd.20200—
+3K182506LipiScan Dynamic Meibomian ImagerTearscience, Inc.20180—
+3K180306NexyNext Sight Srl20182—
+3K142047EIDONCentervue S.P.A.20148—
+3K122572Icam Fundus CameraOptovue, Inc.20138—
+4K250683Resolve Fundus CameraOptain Health, Inc.20250—
+4K222166SOLIXOptovue, Inc.20221—
+4K192113DRSplusCentervue S.P.A.20191—
+4K182199NFC-700 non-mydriatic auto fundus cameraCrystalvue Medical Corporation20193—
+4K180526Eidon FACentervue S.P.A.20182—
+4K180293Retia 2Centervue S.P.A.20180—
+4K150320CompassCentervue S.P.A.20151—
+4K130656IfusionOptovue, Inc.201301
+5K251848Pentacam® Cornea OCTOculus Optikgeräte GmbH20260—
+5K243504Maia (AHMACME001)Centervue S.P.A.20250—
+5K242508Verily Numetric Retinal CameraVerily Life Sciences, LLC20240—
+5K230627Zilia Ocular FC (ZIL-10002)Zilia, Inc.20230—
+5K213705DRSplusCentervue S.P.A.20210—
+5K211328Eidon FA, Eidon, Eidon AF, Eidon UwflCentervue S.P.A.20211—
+5K210197NFC-600 Automated Portable Retinal CameraCrystalvue Medical Corporation20210—
+6K241931OcuMet Beacon (OCUB100)Ocusciences, Inc.20250—