510(k) Report

Devices descending from K961748

1,230 later devices reach Medlite/Erbium Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K171992SculpSureCynosure, Inc.20178—
+12K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+12K163128Epic ProBiolase, Inc.201716—
+12K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+13K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.20260—
+13K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+13K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+13K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+13K234085LUNE™ PureHygieneEnamel Pure20241—
+13K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+13K231971Deka Physiq 360El.En S.P.A.20230—
+13K223838Catalys™ Precision Laser SystemAmo Manufacturing USA, LLC20230—
+13K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V.202310—
+13K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+13K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+13K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+13K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+13K210701CATALYS Precision Laser SystemAmo Manufacturing USA, LLC20211—
+13K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+13K182741SculpSureCynosure20195—
+13K172771Epic Pro 940Biolase, Inc.20171—
+13K172144CoolSculpting SystemZeltiq Aesthetics20177—
+14K260138LUNE PureHygieneEnamel Pure20260—
+14K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+14K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+14K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+14K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+14K220516CATALYS Precision Laser systemAmo Manufacturing USA, LLC20220—
+14K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805
+15K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—