510(k) Report

Devices descending from K100678

11 later devices reach Supra Scan Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122251Vitra MultispotQuantel Medical20131—
+1K121475Txcell Scanning Laser Delivery SystemIridex Corp20126—
+1K120825Supra Scan Delivery SystemQuantel Medical20121—
+2K191962Vitra 2Quantel Medical20190—
+2K170067EasyretQuantel Medical20170—
+2K123542Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc.201351
+3K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)Iridex Corporation20221—
+3K170409PASCAL Synthesis Twinstar Ophthalmic Scanning Laser SystemTopcon Medical Laser Systems, Inc. (Tmls)20170—
+3K141851Navilas Laser SystemOd-Os GmbH20152—
+4K251772Navilas Laser System 577sl (156691)Od-Os GmbH20250—
+4K162191NAVILAS Laser SystemOd-Os GmbH20161—