510(k) Report

Devices descending from K081744

17 later devices reach Pascal Synthesis Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122251Vitra MultispotQuantel Medical20131—
+1K103056Visulas Trion Laser System with the Vite OptionCarl Zeiss Meditec, AG20110—
+1K100678Supra Scan Delivery SystemQuantel Medical201011—
+1K100035Model Visulas 532S Laser with the Vite OptionCarl Zeiss Meditec, AG20104—
+2K191962Vitra 2Quantel Medical20190—
+2K181682VISULAS greenCarl Zeiss Meditec, AG20192—
+2K121475Txcell Scanning Laser Delivery SystemIridex Corp20126—
+2K120825Supra Scan Delivery SystemQuantel Medical20121—
+3K232051VISULAS greenCarl Zeiss Meditec20231—
+3K170067EasyretQuantel Medical20170—
+3K123542Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc.201351
+4K233911VISULAS combiCarl Zeiss Meditec, AG20240—
+4K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)Iridex Corporation20221—
+4K170409PASCAL Synthesis Twinstar Ophthalmic Scanning Laser SystemTopcon Medical Laser Systems, Inc. (Tmls)20170—
+4K141851Navilas Laser SystemOd-Os GmbH20152—
+5K251772Navilas Laser System 577sl (156691)Od-Os GmbH20250—
+5K162191NAVILAS Laser SystemOd-Os GmbH20161—