510(k) Report

Devices descending from K963094

1,185 later devices reach Cynosure Photogenica LP Dermatological Vascular Lesion Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+12K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+12K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+12K171111SculpsureCynosure, Inc.201710—
+12K170500SIROLaser Advance+Dentsply Sirona201721—
+12K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+12K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+12K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+12K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+12K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+12K111689StlaseDental Photonics, Inc.201222—
+13K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+13K254185Potenza PrimeJeisys Medical Incorporated20260—
+13K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+13K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+13K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…Shenzhen Qianyu Technology Co., Ltd.20260—
+13K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+13K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+13K253803MILAN SystemLumenis Be, Ltd.20260—
+13K253750BTL-785NEHBTL Industries, Inc.20260—
+13K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+13K251254Ignite RF SystemInMode, Ltd.20260—
+13K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+13K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+13K252367InbellaMulti SystemInbella Medical, Inc.20250—
+13K252096Light Therapy Decollete Mask (1019135)Merchsource, LLC20250—
+13K251334New Doublo 2.0Hironic Co., Ltd.20250—
+13K250966CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+13K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+13K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+13K242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd20250—
+13K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+13K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+13K242532BTL-785BNF-EBTL Industries, Inc.20241—
+13K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+13K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+13K233642InMode RF SystemInMode, Ltd.20244—
+13K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+13K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+13K230167BACK 4Swims America Corp20230—
+13K230037BACK 3Swims America Corp20230—
+13K222226EONDominion Aesthetic Technologies, Inc.20230—
+13K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+13K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+13K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+13K214103Shani Darden LED light therapy maskHarpar Grace International202219—
+13K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+13K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+13K212331BodySculpRohrer Aesthetics, LLC20211—
+13K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+13K192970SlimusHironic Co., Ltd.20200—
+13K200693K2 MobileHulaser, Inc.20202—
+13K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+13K193486Epic 980Biolase, Inc.20202—
+13K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+13K180044SIROLaser BlueDentsply Sirona201812—
+13K171992SculpSureCynosure, Inc.20178—
+13K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+13K163128Epic ProBiolase, Inc.201716—
+13K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+14K261701Hemolase 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—
+14K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+14K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+14K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+14K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+14K240780InMode RF SystemInMode, Ltd.20243—
+14K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+14K234085LUNE™ PureHygieneEnamel Pure20241—
+14K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+14K231971Deka Physiq 360El.En S.P.A.20230—
+14K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V.202310—
+14K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+14K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+14K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+14K182741SculpSureCynosure20195—
+14K172771Epic Pro 940Biolase, Inc.20171—
+14K172144CoolSculpting SystemZeltiq Aesthetics20177—
+15K260138LUNE PureHygieneEnamel Pure20260—
+15K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+15K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+15K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+15K243737Inbella RF SystemInbella Medical, Inc.20250—
+15K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+15K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805
+16K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—