510(k) Report

Devices descending from K993685

23 later devices reach Biopack through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031612Alt Laser, Model VTR 75Avicenna Laser Technology, Inc.200322—
+2K132529Gallieon-1 Medical LaserFuture Device and Technology, Inc.20140—
+2K112016L-Ser KO LampYa-Man, Ltd.20120—
+2K091726Nexus Xpulse 805 IR Lamp System, Nexus Xpulse 980 IR Lamp System, Model 805, 980Usa Laser Biotech, Inc.20096—
+2K091285AL T Laser, Model Avi HPLL-12Avicenna Laser Technology, Inc.20090—
+2K083560Expanded Spectrum Photo Therapy Device, Model Espt-3XLighthouse Technical Innovations, Inc.20081—
+2K070400LC Therapy, Model LCT-1000Litecure, LLC20078—
+2K052814Lumina 1600, 3300 and 6600 SystemsUsa Laser Biotech, Inc.20058—
+2K050070K-Laser, Models 3,4,4D,6DEltech S.R.L200512—
+2K041885Bioflex LD-175 and LD-1200 Treatment HeadsMeditech International, Inc.20052—
+3K101893Nexus Biowave 7W Lite IR Lamp System, Nexus Biowave 10W Lite IR Lamp System, Nexus…Usa Laser Biotech, Inc.20115—
+3K103511Litecure Therapy SystemLitecure, LLC20110—
+3K091497K-Laser K-1200, Model 12 WEltech S.R.L20097—
+3K081355Bioflex LD-R100 Treatment HeadMeditech International, Inc.20080—
+3K061656Laser-D68Laser Pain Clinics LP20065—
+3K051875Bioflex Prescription System and Related Treatment HeadsMeditech International, Inc.20061—
+4K171087AXON IR Heat LampCrystal Medtech, LLC20170—
+4K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+4K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+4K151629Guardian 1000Quanta System Spa20150—
+4K151521Phoenix Thera-Lase SystemPhoenix Thera-Lase Systems, LLC20150—
+4K141564Opton ProZimmer Medizinsystems GmbH20140—
+4K120604K-LaserEltech S.R.L20124—