510(k) Report

Devices descending from K091497

7 later devices reach K-Laser K-1200, Model 12 W through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141564Opton ProZimmer Medizinsystems GmbH20140—
+1K120604K-LaserEltech S.R.L20124—
+1K103511Litecure Therapy SystemLitecure, LLC20110—
+2K171087AXON IR Heat LampCrystal Medtech, LLC20170—
+2K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+2K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+2K151521Phoenix Thera-Lase SystemPhoenix Thera-Lase Systems, LLC20150—