510(k) Report

Devices descending from K030186

680 later devices reach Polris LV through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+8K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+8K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+8K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+8K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+8K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+8K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+8K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+8K242349FoLixLumenis Be, Ltd.20240—
+8K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+8K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+8K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+8K240752Deka ToroEl.En S.P.A.20240—
+8K233766Geneo X ElitePollogen, Ltd.20240—
+8K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+8K234085LUNE™ PureHygieneEnamel Pure20241—
+8K233642InMode RF SystemInMode, Ltd.20244—
+8K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+8K232424CurrentBody Skin RFEl Global Trade, Ltd.20240—
+8K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+8K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+8K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+8K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+8K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+8K223110truSculpt iDCutera, Inc.20221—
+8K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+8K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+8K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+8K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+8K211107BTL-899 FPBTL Industries, Inc.20213—
+8K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+8K200241TempSure SystemCynosure, LLC202013—
+8K183450EmBody SystemInmode MD, Ltd.20198—
+8K180406Ellipse YdunEllipse A/S20180—
+8K172771Epic Pro 940Biolase, Inc.20171—
+8K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+8K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+9K260138LUNE PureHygieneEnamel Pure20260—
+9K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+9K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+9K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+9K253007Laser 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—
+9K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+9K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+9K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+9K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+9K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+9K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+9K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+9K240780InMode RF SystemInMode, Ltd.20243—
+9K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+9K212891TempSure SystemCynosure, LLC20221—
+9K213344BTL-899ABTL Industries, Inc.20222—
+9K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+9K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+9K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+9K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+10K261701Hemolase 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—
+10K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+10K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+10K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+10K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+10K243737Inbella RF SystemInbella Medical, Inc.20250—
+10K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K230467BTL-899FBTL Industries, Inc.20231—
+10K230167BACK 4Swims America Corp20230—
+10K230037BACK 3Swims America Corp20230—
+10K223292TempSure SystemCynosure, LLC20220—
+10K213889PicoStarAsclepion Laser Technologies GmbH20220—
+10K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+11K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+11K202503ChromeQuanta System Spa202012—
+12K253765Vanish ProDdc Technologies, Inc.20260—
+12K241527Pastelle ProWontech Co., Ltd.20253—
+12K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+12K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+12K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+13K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—