510(k) Report

Devices descending from K030805

363 later devices reach Mythos 500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+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—
+8K241600DermablateAsclepion Laser Technologies GmbH20240—
+8K234085LUNE™ PureHygieneEnamel Pure20241—
+8K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+8K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+8K232709Diode laser therapy deviceHebei Zhemai Technology Co., Ltd.20231—
+8K231901Hakon, Hakon SmartMedical San Indústria DE Equipamentos Médicos Ltda.20230—
+8K230362Planar LED mateShenzhen Leaflife Technology Co., Ltd.20230—
+8K231054V-LaserWontech Co., Ltd.20231—
+8K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+8K223540AvalancheLase FamilyFotona D.O.O.20230—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K221312Diode Laser Hair Removal DeviceGuangzhou Chuang Zao Mei Technology Co., Ltd.20224—
+8K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K202288FinebeamSNJ Co., Ltd.20212—
+8K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+8K212978Diode laser therapy systemBeijing Unt Technology Co., Ltd.20211—
+8K212793Laser Treatment System, Model: Hera, ArmoCanadian Pioneer Medical Technology Corporation20210—
+8K203788DermaV Laser SystemLutronic Corporation202101
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+8K202172StarWalkerFotona D.O.O.20203—
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K183156V-LaserWontech Co., Ltd.20193—
+8K181518Sebacia MicroparticlesSebacia, Inc.20180—
+8K172771Epic Pro 940Biolase, Inc.20171—
+8K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+8K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+9K252723Dynamis Pro FamilyFotona D.O.O.20260—
+9K260138LUNE PureHygieneEnamel Pure20260—
+9K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+9K260307Diode Laser Therapy Systems (V19)Weifang Mingliang Electronics Co., Ltd.20260—
+9K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+9K253342PICO-KSpeclipse, Inc.20251—
+9K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+9K253344Bellus-QSpeclipse, Inc.20250—
+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—
+9K251801Diode laser device (BM091)Hebei Newangie Technology Co., Ltd.20250—
+9K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+9K250431Medical Diode Laser Hair Removal System (MNLT-D1)Shandong Moonlight Electronics Tech Co., Ltd.20251—
+9K251094Alma VeilWontech Co., Ltd.20250—
+9K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+9K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+9K243465Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device…Guangzhou Chuang Zao Mei Technology Co., Ltd.20250—
+9K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+9K241498Diode laser Treatment System (K18)Hebei Keylaser Sci-Tech Co.,Ltd20240—
+9K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+9K221427V-LaserWontech Co., Ltd.20222—
+9K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+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—
+10K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+10K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+10K252048808nm semiconductor laser hair removal machineXi'An Taibo Electronic Technology Co., Ltd.20260—