510(k) Report

Devices descending from K121475

6 later devices reach Txcell Scanning Laser Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123542Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc.201351
+2K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)Iridex Corporation20221—
+2K170409PASCAL Synthesis Twinstar Ophthalmic Scanning Laser SystemTopcon Medical Laser Systems, Inc. (Tmls)20170—
+2K141851Navilas Laser SystemOd-Os GmbH20152—
+3K251772Navilas Laser System 577sl (156691)Od-Os GmbH20250—
+3K162191NAVILAS Laser SystemOd-Os GmbH20161—