510(k) Report

Devices descending from K111108

15 later devices reach Pascal Streamline 577 (with Accessories) through their predicates, nearest generation first.

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