510(k) Report

Devices descending from K051537

47 later devices reach Hilt Family Laser: Hilt I, Hilt II, Hilt Iii through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141861Hilthera 4.0Jeisys Medical, Inc.201520—
+1K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+2K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+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—
+2K150724SculpSureCynosure, Inc.201521—
+2K150230SculpSureCynosure, Inc.201521—
+3K193656SkyPulseFotona D.O.O.202011—
+3K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+3K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+3K160470SculpSureCynosure, Inc.201620—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+4K211681EONDominion Aesthetic Technologies, Inc.20221—
+4K212331BodySculpRohrer Aesthetics, LLC20211—
+4K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+4K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+4K190743Venus BlissVenus Concept USA, Inc.20194—
+4K171111SculpsureCynosure, Inc.201710—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+5K233099GladiatorRohrer Aesthetics, LLC20240—
+5K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+5K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K222226EONDominion Aesthetic Technologies, Inc.20230—
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+5K192970SlimusHironic Co., Ltd.20200—
+5K171992SculpSureCynosure, Inc.20178—
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+6K231971Deka Physiq 360El.En S.P.A.20230—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—
+6K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+6K182741SculpSureCynosure20195—
+7K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+7K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—