510(k) Report

Devices descending from K030527

856 later devices reach Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K252367InbellaMulti SystemInbella Medical, Inc.20250—
+10K251334New Doublo 2.0Hironic Co., Ltd.20250—
+10K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+10K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+10K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+10K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+10K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+10K242532BTL-785BNF-EBTL Industries, Inc.20241—
+10K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K233642InMode RF SystemInMode, Ltd.20244—
+10K211681EONDominion Aesthetic Technologies, Inc.20221—
+10K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+10K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+10K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+10K190743Venus BlissVenus Concept USA, Inc.20194—
+10K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+10K171111SculpsureCynosure, Inc.201710—
+10K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+11K261701Hemolase 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—
+11K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+11K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+11K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+11K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+11K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+11K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K240780InMode RF SystemInMode, Ltd.20243—
+11K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+11K230167BACK 4Swims America Corp20230—
+11K230037BACK 3Swims America Corp20230—
+11K222226EONDominion Aesthetic Technologies, Inc.20230—
+11K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+11K213889PicoStarAsclepion Laser Technologies GmbH20220—
+11K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+11K212331BodySculpRohrer Aesthetics, LLC20211—
+11K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+11K192970SlimusHironic Co., Ltd.20200—
+11K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+11K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+11K171992SculpSureCynosure, Inc.20178—
+11K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+12K243737Inbella RF SystemInbella Medical, Inc.20250—
+12K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+12K231971Deka Physiq 360El.En S.P.A.20230—
+12K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+12K202503ChromeQuanta System Spa202012—
+12K182741SculpSureCynosure20195—
+12K172144CoolSculpting SystemZeltiq Aesthetics20177—
+13K253765Vanish ProDdc Technologies, Inc.20260—
+13K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+13K241527Pastelle ProWontech Co., Ltd.20253—
+13K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+13K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+13K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+13K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+13K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805
+14K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—