510(k) Report

Devices descending from K071687

38 later devices reach Famili of Iridex IQ Laser Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230228Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)Iridex Corporation20230—
+1K201502Vitra 810Quantel Medical20200—
+1K170718Iridex TruFocus LIO PremiereIridex Corporation201731
+1K151109Lumenis Smart532 Laser SystemLumenis, Inc.20150—
+1K143154IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe (RFID)Iridex Corporation20153—
+1K141851Navilas Laser SystemOd-Os GmbH20152—
+1K133486Stellaris PC Vision Enhancement SystemBausch & Lomb201473
+1K121475Txcell Scanning Laser Delivery SystemIridex Corp20126—
+1K120825Supra Scan Delivery SystemQuantel Medical20121—
+1K111643Opto Mitra Yellow LaserOpto Electronica SA20110—
+1K111108Pascal Streamline 577 (with Accessories)Topcon Medical Laser Systems, Inc.201115—
+1K091981Lightlas 577 Medical Optical Pumped Semiconductor LaserLightmed Corp.20090—
+1K091581Supra 577.Y LaserQuantel Medical200916—
+2K213592Iridex 810 LaserIridex Corporation20220—
+2K201623LION PhotocoagulatorNorlase Aps20201—
+2K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…D.O.R.C. Dutch Ophthalmic Research Center (International)201921
+2K181662Iridex TruFocus LIO PremiereIridex Corporation20180—
+2K171488PSLT for PASCAL StreamlineTopcon Medical Laser Systems, Inc.20171—
+2K170067EasyretQuantel Medical20170—
+2K163632Katalyst Cyclophotocoagulation ProbeKatalyst Surgical, LLC20170—
+2K170052Stellaris Elite vision enhancement systemBausch+Lomb20171—
+2K162342Stellaris Elite Vision Enhancement SystemBausch+Lomb2017113
+2K162191NAVILAS Laser SystemOd-Os GmbH20161—
+2K162416IRIDEX Cyclo G6 Laser System, G-Probe IlluminateIridex Corporation20161—
+2K142172Lightmed Truscan 577Lightmed Corp.20151—
+2K130195Scanning LaserlinkLumenis, Inc.201301
+2K123542Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc.201351
+2K123056Pascal Laser Indirect OphthalmoscopeTopcon Medical Laser Systems, Inc. (Tmls)20120—
+3K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack (s)…Bausch and Lomb20260—
+3K251507Integre LioQuantel Medical20260—
+3K251772Navilas Laser System 577sl (156691)Od-Os GmbH20250—
+3K232084Stellaris Elite vision enhancement systemBausch and Lomb20240—
+3K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)Iridex Corporation20221—
+3K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International)202216
+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—
+4K250501System SophiThis AG20250—