510(k) Report

Devices descending from K024064

681 later devices reach Polaris DS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+9K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+9K253803MILAN SystemLumenis Be, Ltd.20260—
+9K260138LUNE PureHygieneEnamel Pure20260—
+9K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+9K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+9K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+9K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+9K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+9K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+9K251254Ignite RF SystemInMode, Ltd.20260—
+9K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, 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—
+9K252367InbellaMulti SystemInbella Medical, Inc.20250—
+9K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+9K251334New Doublo 2.0Hironic Co., Ltd.20250—
+9K250734OptiLUV DevicePollogen, Ltd.20250—
+9K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+9K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+9K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+9K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+9K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K242349FoLixLumenis Be, Ltd.20240—
+9K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+9K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+9K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+9K240752Deka ToroEl.En S.P.A.20240—
+9K233766Geneo X ElitePollogen, Ltd.20240—
+9K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+9K233642InMode RF SystemInMode, Ltd.20244—
+9K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+9K232424CurrentBody Skin RFEl Global Trade, Ltd.20240—
+9K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+9K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+9K223110truSculpt iDCutera, Inc.20221—
+9K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+9K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+9K211107BTL-899 FPBTL Industries, Inc.20213—
+9K200241TempSure SystemCynosure, LLC202013—
+9K183450EmBody SystemInmode MD, Ltd.20198—
+9K180406Ellipse YdunEllipse A/S20180—
+9K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+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—
+10K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+10K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+10K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+10K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+10K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+10K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K240780InMode RF SystemInMode, Ltd.20243—
+10K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+10K212891TempSure SystemCynosure, LLC20221—
+10K213344BTL-899ABTL Industries, Inc.20222—
+10K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+10K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+10K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+10K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+11K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+11K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+11K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+11K243737Inbella RF SystemInbella Medical, Inc.20250—
+11K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K230467BTL-899FBTL Industries, Inc.20231—
+11K230167BACK 4Swims America Corp20230—
+11K230037BACK 3Swims America Corp20230—
+11K223292TempSure SystemCynosure, LLC20220—
+11K213889PicoStarAsclepion Laser Technologies GmbH20220—
+11K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+12K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+12K202503ChromeQuanta System Spa202012—
+13K253765Vanish ProDdc Technologies, Inc.20260—
+13K241527Pastelle ProWontech Co., Ltd.20253—
+13K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+13K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+13K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+14K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—