510(k) Report

Devices descending from K111505

8 later devices reach Rtvue Cam with Corneal Power Upgrade through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180660AvantiOptovue, Inc.20185—
+1K121622Nidek RS-3000Nidek Co., Ltd.20131—
+2K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software…Nidek Co., Ltd.20230—
+2K222166SOLIXOptovue, Inc.20221—
+2K213265Tomey Cornea/Anterior Segment OCT CASIA2Tomey Corporation20221—
+2K132323RS-3000 AdvanceNidek Co., Ltd.20140—
+3K251848Pentacam® Cornea OCTOculus Optikgeräte GmbH20260—
+3K250553Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey Corporation20250—