510(k) Report

Devices descending from K945861

979 later devices reach Bergen 710 Esu through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+13K261701Hemolase 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—
+13K253803MILAN SystemLumenis Be, Ltd.20260—
+13K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+13K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+13K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+13K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+13K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+13K251254Ignite RF SystemInMode, Ltd.20260—
+13K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd.20260—
+13K252367InbellaMulti SystemInbella Medical, Inc.20250—
+13K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+13K252096Light Therapy Decollete Mask (1019135)Merchsource, LLC20250—
+13K251334New Doublo 2.0Hironic Co., Ltd.20250—
+13K250734OptiLUV DevicePollogen, Ltd.20250—
+13K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+13K250966CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+13K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+13K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+13K242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd20250—
+13K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+13K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+13K242349FoLixLumenis Be, Ltd.20240—
+13K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+13K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+13K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+13K240752Deka ToroEl.En S.P.A.20240—
+13K233766Geneo X ElitePollogen, Ltd.20240—
+13K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+13K233642InMode RF SystemInMode, Ltd.20244—
+13K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+13K232424CurrentBody Skin RFEl Global Trade, Ltd.20240—
+13K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+13K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+13K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+13K223110truSculpt iDCutera, Inc.20221—
+13K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+13K214103Shani Darden LED light therapy maskHarpar Grace International202219—
+13K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+13K211107BTL-899 FPBTL Industries, Inc.20213—
+13K200241TempSure SystemCynosure, LLC202013—
+13K183450EmBody SystemInmode MD, Ltd.20198—
+13K180406Ellipse YdunEllipse A/S20180—
+13K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+14K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+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—
+14K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+14K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+14K240780InMode RF SystemInMode, Ltd.20243—
+14K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+14K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V.202310—
+14K212891TempSure SystemCynosure, LLC20221—
+14K213344BTL-899ABTL Industries, Inc.20222—
+14K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+14K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+14K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+14K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+15K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+15K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+15K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+15K243737Inbella RF SystemInbella Medical, Inc.20250—
+15K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+15K230467BTL-899FBTL Industries, Inc.20231—
+15K230167BACK 4Swims America Corp20230—
+15K230037BACK 3Swims America Corp20230—
+15K223292TempSure SystemCynosure, LLC20220—
+15K213889PicoStarAsclepion Laser Technologies GmbH20220—
+15K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+16K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+16K202503ChromeQuanta System Spa202012—
+17K253765Vanish ProDdc Technologies, Inc.20260—
+17K241527Pastelle ProWontech Co., Ltd.20253—
+17K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+17K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+17K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+18K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—