510(k) Report

Devices descending from K091581

16 later devices reach Supra 577.Y Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141851Navilas Laser SystemOd-Os GmbH20152—
+1K111108Pascal Streamline 577 (with Accessories)Topcon Medical Laser Systems, Inc.201115—
+2K171488PSLT for PASCAL StreamlineTopcon Medical Laser Systems, Inc.20171—
+2K162191NAVILAS Laser SystemOd-Os GmbH20161—
+2K142172Lightmed Truscan 577Lightmed Corp.20151—
+2K130195Scanning LaserlinkLumenis, Inc.201301
+2K123542Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc.201351
+2K121475Txcell Scanning Laser Delivery SystemIridex Corp20126—
+2K123056Pascal Laser Indirect OphthalmoscopeTopcon Medical Laser Systems, Inc. (Tmls)20120—
+2K120825Supra Scan Delivery SystemQuantel Medical20121—
+3K251772Navilas Laser System 577sl (156691)Od-Os GmbH20250—
+3K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)Iridex Corporation20221—
+3K190448LightLas Pattern Scanning System - TruScan ProLight-Med (Usa), Inc.20190—
+3K180402PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStarTopcon Medical Laser Systems, Inc.20180—
+3K170409PASCAL Synthesis Twinstar Ophthalmic Scanning Laser SystemTopcon Medical Laser Systems, Inc. (Tmls)20170—
+3K170067EasyretQuantel Medical20170—