510(k) Report

Devices descending from K040131

569 later devices reach Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K162781Magma SparkFormatk Systems, Ltd.20160—
+8K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+8K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+8K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+8K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+9K254185Potenza PrimeJeisys Medical Incorporated20260—
+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—
+9K253750BTL-785NEHBTL Industries, Inc.20260—
+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—
+9K252367InbellaMulti SystemInbella Medical, Inc.20250—
+9K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+9K251334New Doublo 2.0Hironic Co., Ltd.20250—
+9K250734OptiLUV DevicePollogen, Ltd.20250—
+9K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+9K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+9K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+9K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+9K242532BTL-785BNF-EBTL Industries, Inc.20241—
+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—
+9K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+9K233642InMode RF SystemInMode, Ltd.20244—
+9K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+9K232106Air Gap FiberWontech Co., Ltd.20240—
+9K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+9K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+9K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+9K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+9K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+9K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+9K200234Surgical laser fibersQuanta System Spa20202—
+9K183450EmBody SystemInmode MD, Ltd.20198—
+9K163197Cook Holmium Laser FiberCook Incorporated20170—
+9K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+9K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+10K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+10K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+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—
+10K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+10K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+10K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+10K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K240780InMode RF SystemInMode, Ltd.20243—
+10K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+10K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+10K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+10K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+10K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+10K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+11K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+11K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+11K253007Laser 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—
+11K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+11K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+11K243737Inbella RF SystemInbella Medical, Inc.20250—
+11K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K230167BACK 4Swims America Corp20230—
+11K230037BACK 3Swims America Corp20230—
+12K261701Hemolase 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—