510(k) Report

Devices descending from K052324

456 later devices reach Polaris LV, Lva Applicator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K172771Epic Pro 940Biolase, Inc.20171—
+7K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+7K163222Discovery Pico FamilyQuanta System Spa201630—
+7K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+8K260138LUNE PureHygieneEnamel Pure20260—
+8K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+8K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+8K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+8K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+8K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+8K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+8K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+8K253007Laser 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—
+8K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+8K250734OptiLUV DevicePollogen, Ltd.20250—
+8K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+8K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+8K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+8K243139Reverso Pro SystemIndiba S. A. U.20250—
+8K242598DEFINE System (AG612444A)InMode, 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—
+8K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+8K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+8K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+8K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+8K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+8K183450EmBody SystemInmode MD, Ltd.20198—
+8K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+9K261701Hemolase 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—
+9K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+9K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+9K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+9K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+9K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+10K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+10K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+10K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K230167BACK 4Swims America Corp20230—
+10K230037BACK 3Swims America Corp20230—
+10K213889PicoStarAsclepion Laser Technologies GmbH20220—
+10K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+11K202503ChromeQuanta System Spa202012—
+12K253765Vanish ProDdc Technologies, Inc.20260—
+12K250281Deka LotusEl.En S.P.A.20250—
+12K241527Pastelle ProWontech Co., Ltd.20253—
+12K233473Deka LotusEl.En S.P.A.20241—
+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—