510(k) Report

Devices descending from K123542

5 later devices reach Pascal Synthesis (532NM/577NM) Opthalmic Laser through their predicates, nearest generation first.

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