510(k) Report

Devices descending from K981952

763 later devices reach Combination ND:Yag and Frequency Doubled Solid State Green Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+8K150027CYMAWhitecap Technologies, LLC20150—
+8K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+8K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+8K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+8K132754Neogen PSR SystemEnergist, Ltd.20132—
+8K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+8K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+8K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+8K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+8K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+8K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+8K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+8K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+9K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+9K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+9K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+9K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+9K253123CuRAS hybridClassys, Inc.20250—
+9K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+9K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+9K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+9K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+9K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K244060eCO2 3DLutronic Corporation20250—
+9K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+9K250281Deka LotusEl.En S.P.A.20250—
+9K241270BTL-754BTL Industries, Inc.20251—
+9K243139Reverso Pro SystemIndiba S. A. U.20250—
+9K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+9K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+9K242349FoLixLumenis Be, Ltd.20240—
+9K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+9K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+9K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+9K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+9K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+9K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+9K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+9K232106Air Gap FiberWontech Co., Ltd.20240—
+9K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+9K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+9K223727LavieenWontech Co., Ltd.20234—
+9K230077LaserMENeauvia North America20232—
+9K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+9K222685NIRA Model 2Dermal Photonics Corp20230—
+9K221873NeoGen PSR SystemEnergist Limited20230—
+9K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+9K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+9K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+9K213674CellFX SystemPulse Biosciences, Inc.20220—
+9K222075CellFX SystemPulse Biosciences, Inc.20220—
+9K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+9K221671CellFX® SystemPulse Biosciences, Inc.20220—
+9K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+9K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+9K211639BTL-785WBTL Industries, Inc.20227—
+9K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+9K212107ReversoIntelis Instruments, Ltd.20211—
+9K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+9K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+9K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+9K200234Surgical laser fibersQuanta System Spa20202—
+9K192545PotenzaJeisys Medical Incorporated202020—
+9K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+9K191855EmFace DeviceInmode MD, Ltd.20191—
+9K181095RF-ReliefEl Global Trade, Ltd.20181—
+9K173503Pollogen Legend SystemPollogen, Ltd.20183—
+9K172302InMode PLUS SystemInmode MD, Ltd.201713—
+9K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+9K172096FraxisIlooda Co,., Ltd.20172—
+9K170325Secret RFIlooda Co,., Ltd.201710—
+9K163197Cook Holmium Laser FiberCook Incorporated20170—
+9K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+9K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+9K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+9K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+10K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+10K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+10K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+10K250734OptiLUV DevicePollogen, Ltd.20250—
+10K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+10K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+10K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+10K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+10K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+10K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+10K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+10K241406LavieenWontech Co., Ltd.20242—
+10K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+10K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+10K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+10K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+10K222556BTL-785XBTL Industries, Inc.20235—
+10K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+10K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+10K210084SilkroHironic Co., Ltd.20223—
+10K220793InnoVoyce Laser FiberInnovoyce, LLC20220—