510(k) Report

Devices descending from K041943

11 later devices reach Xtrac XL, Model AL8000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073659Xtrac Ultra 2, Model AL10000Photo Medex, Inc.20087—
+1K062963Pharos Excimer Laser System, Model EX-308Ra Medical Systems,Inc200732
+2K230076Enhanced AURORA™ Medical Diode System, and related accessoriesPsoria-Shield, Inc.20230—
+2K193478XTRAC Momentum Excimer Laser SystemStrata Skin Sciences, Inc.20201—
+2K181480MMD TipStrata Skin Sciences, Inc.20180—
+2K172639PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd.20172—
+2K103540Psoria-LightPsoria-Shield, Inc.20113—
+3K223588PALLAS PremiumLaseroptek Co., Ltd.20230—
+3K192411Psoria-Shield AURORAPsoria-Shield20202—
+3K191501PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd.20201—
+4K254234Phototherapy System (DUV-COMBO)Choyang Medics Co., Ltd.20260—