510(k) Report

Devices descending from K980517

1,509 later devices reach Epilaser Normal Mode Ruby Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+7K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+7K123483Diode LaserBeijing Syntech Laser CO., LTD.201353—
+7K123889Acleara, TheraclearTheravant Corporation20130—
+7K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+7K121327Diolase 10SBiolase Technology, Inc.20132—
+7K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+7K111501I-Lipo SystemChromogenex Technologies Limited201215—
+7K110375Blueshine's Gold SeriesBlueshine Srl20124—
+7K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+7K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+7K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+7K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+7K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+7K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+7K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+7K082938EzlaseBiolase Technology, Inc.200850—
+7K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+7K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+7K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+7K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+7K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+8K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+8K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC20260—
+8K253504Volnewmer™Classys, Inc.20260—
+8K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+8K260594IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP…Shenzhen Xiazhifeng Electronic Co., Ltd.20260—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.20260—
+8K260742Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+8K253750BTL-785NEHBTL Industries, Inc.20260—
+8K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+8K254047Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07…Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+8K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—
+8K253666IPL Hair Removal Device (Models: T31A, T32A)Shenzhen Mlay Intelligent Technology Co., Ltd.20260—
+8K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+8K253279Feather/numiere 05 06 07 (05)Heat IN A Click, LLC20250—
+8K252187Aura Glide (FC40)Aura Medical, LLC20250—
+8K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd.20251—
+8K252618IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)Alovea Healthcare Co., Ltd.20250—
+8K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+8K251914IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal…Miley Technology (Hebei) Co., Ltd.20250—
+8K251843Erchonia EVRLErchonia Corporation20250—
+8K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+8K244060eCO2 3DLutronic Corporation20250—
+8K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+8K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+8K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+8K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+8K250938Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01…Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+8K250384IPL400El Global Trade, Ltd.20250—
+8K250532Solawave 2-in-1 Skincare Mini (Model: 61043)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+8K250171IPL Hair Removal Device (BE965A, BE965B, BE965C)Shenzhen Yang WO Electronic Co., Ltd.20251—
+8K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+8K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+8K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.20250—
+8K243393JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)Shenzhen Ulike Smart Electronics Co., Ltd.20251—
+8K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd.20253—
+8K243139Reverso Pro SystemIndiba S. A. U.20250—
+8K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+8K242532BTL-785BNF-EBTL Industries, Inc.20241—
+8K240897CellinewVIOL Co., Ltd.20240—
+8K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+8K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+8K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+8K242349FoLixLumenis Be, Ltd.20240—
+8K241881IPL Hair Removal Device (JM-843, JM-865, JM-638)Shenzhen Junmei Technology Co., Ltd.20241—
+8K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+8K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+8K233344Regenalase Laser SystemIpg Medical20240—
+8K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+8K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+8K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+8K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.20242—
+8K240313Oligio XWontech Co., Ltd.20241—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+8K232708Intense pulsed light therapy deviceHebei Zhemai Technology Co., Ltd.20230—
+8K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+8K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+8K232499IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)Shenzhen Lescolton Electrical Appliance Co., Ltd.20234—
+8K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+8K223727LavieenWontech Co., Ltd.20234—
+8K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+8K230293TheraFace MaskTherabody, Inc.202316—
+8K223893Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V.20235—
+8K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.20239—
+8K230097IPL Hair Removal Device, Model (s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108Shenzhen Bsx Technology Electronics Co., Ltd.20238—
+8K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+8K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc.20222—