510(k) Report

Devices descending from K030719

18 later devices reach Pentacam Scheimpflug Camera through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152311Pentacam AXLOculus Optikgerate GmbH201633
+1K143086VX120 Ophthalmic Diagnostic DeviceLuneau Sas20153—
+1K133132Optical Biometer AL-ScanNidek Co., Ltd.201401
+1K111505Rtvue Cam with Corneal Power UpgradeOptovue, Inc.201181
+1K071183Allegro OculyzerWavelight AG20070—
+2K202989Myopia MasterOculus Optikgeräte GmbH202101
+2K201724Pentacam AXL WaveOculus Optikgerate GmbH202002
+2K182659Galilei G6 Lens ProfessionalSis Ag, Surgical Instrument Systems20190—
+2K180660AvantiOptovue, Inc.20185—
+2K162067VX130 Ophthalmic Diagnostic DeviceLuneau Sas20171—
+2K121622Nidek RS-3000Nidek Co., Ltd.20131—
+3K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software…Nidek Co., Ltd.20230—
+3K222166SOLIXOptovue, Inc.20221—
+3K213265Tomey Cornea/Anterior Segment OCT CASIA2Tomey Corporation20221—
+3K202221VX650Luneau Technology Operations20210—
+3K132323RS-3000 AdvanceNidek Co., Ltd.20140—
+4K251848Pentacam® Cornea OCTOculus Optikgeräte GmbH20260—
+4K250553Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey Corporation20250—