510(k) Report

Devices descending from K914136

1,315 later devices reach Coherent Versapulse (TM) 2.1XE/2.1L Holmi Surg Lase through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+9K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+9K141868Tria FanpTria Beauty, Inc.20140—
+9K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+9K140120EPIC 10Biolase, Inc.20141—
+9K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+9K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+9K133364Picosure WorkstationCynosure, Inc.201451—
+9K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+9K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+9K132754Neogen PSR SystemEnergist, Ltd.20132—
+9K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+9K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+9K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+9K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+9K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+9K121346Picosure WorkstationCynosure, Inc.201287—
+9K121286EPIC 10Biolase Technology, Inc.201231—
+9K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201217—
+9K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+9K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+9K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+9K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+9K120735Pathassit Light SeekerEntellus Medical, Inc.20121—
+9K111501I-Lipo SystemChromogenex Technologies Limited201215—
+9K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+9K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+9K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+9K094049Stlase Diode LaserDental Photonics, Inc.201023—
+9K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+9K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+9K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+9K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+10K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+10K254185Potenza PrimeJeisys Medical Incorporated20260—
+10K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+10K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+10K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC20260—
+10K253803MILAN SystemLumenis Be, Ltd.20260—
+10K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+10K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.20260—
+10K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+10K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+10K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+10K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—
+10K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+10K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+10K251254Ignite RF SystemInMode, Ltd.20260—
+10K253279Feather/numiere 05 06 07 (05)Heat IN A Click, LLC20250—
+10K252187Aura Glide (FC40)Aura Medical, LLC20250—
+10K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd.20251—
+10K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+10K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+10K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+10K252367InbellaMulti SystemInbella Medical, Inc.20250—
+10K251334New Doublo 2.0Hironic Co., Ltd.20250—
+10K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+10K242859VEGAIbramed Equipamentos Médicos20250—
+10K251843Erchonia EVRLErchonia Corporation20250—
+10K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+10K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+10K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+10K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+10K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+10K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+10K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+10K250532Solawave 2-in-1 Skincare Mini (Model: 61043)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+10K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+10K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+10K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+10K250809Stellar M22Lumenis Be, Ltd.20250—
+10K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+10K250200InbellaBody SystemInbella Medical, Inc.20250—
+10K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+10K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.20250—
+10K243393JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)Shenzhen Ulike Smart Electronics Co., Ltd.20251—
+10K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd.20253—
+10K243139Reverso Pro SystemIndiba S. A. U.20250—
+10K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+10K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+10K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+10K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+10K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+10K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+10K241656Eneka SelectifTermosalud20241—
+10K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+10K241600DermablateAsclepion Laser Technologies GmbH20240—
+10K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+10K233473Deka LotusEl.En S.P.A.20241—
+10K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+10K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+10K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.20242—
+10K233642InMode RF SystemInMode, Ltd.20244—
+10K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+10K232236EchoQuanta System Spa20230—
+10K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+10K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+10K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+10K223033Tixel® 2 SystemNovoxel, Ltd.20230—