510(k) Report

Devices descending from K020839

1,046 later devices reach Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K173503Pollogen Legend SystemPollogen, Ltd.20183—
+8K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+8K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+8K170500SIROLaser Advance+Dentsply Sirona201721—
+8K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+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—
+8K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+8K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+8K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+8K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+8K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+8K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+8K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+8K111689StlaseDental Photonics, Inc.201222—
+9K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+9K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…Shenzhen Qianyu Technology Co., Ltd.20260—
+9K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+9K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+9K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+9K252096Light Therapy Decollete Mask (1019135)Merchsource, LLC20250—
+9K250966CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd20250—
+9K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+9K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+9K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+9K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+9K233123SilkroHironic Co., Ltd.20241—
+9K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+9K233099GladiatorRohrer Aesthetics, LLC20240—
+9K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+9K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+9K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+9K232106Air Gap FiberWontech Co., Ltd.20240—
+9K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+9K233147PiXel8-RFRohrer Aesthetics20230—
+9K222556BTL-785XBTL Industries, Inc.20235—
+9K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+9K211000AcutronIlooda Co,., Ltd.20220—
+9K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+9K214103Shani Darden LED light therapy maskHarpar Grace International202219—
+9K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+9K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+9K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+9K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+9K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+9K201685PotenzaJeisys Medical, Inc.20219—
+9K201735PlaDuo SystemShenB Co., Ltd.20203—
+9K200693K2 MobileHulaser, Inc.20202—
+9K202503ChromeQuanta System Spa202012—
+9K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+9K193486Epic 980Biolase, Inc.20202—
+9K200234Surgical laser fibersQuanta System Spa20202—
+9K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+9K180044SIROLaser BlueDentsply Sirona201812—
+9K163197Cook Holmium Laser FiberCook Incorporated20170—
+9K163128Epic ProBiolase, Inc.201716—
+9K160470SculpSureCynosure, Inc.201620—
+9K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+9K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+9K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+9K150724SculpSureCynosure, Inc.201521—
+9K150230SculpSureCynosure, Inc.201521—
+9K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+10K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+10K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+10K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+10K251334New Doublo 2.0Hironic Co., Ltd.20250—
+10K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+10K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+10K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology 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—
+10K242688Finiff SystemSkingrab Co., Ltd.20240—
+10K231216PotenzaJeisys Medical, Inc.20244—
+10K231287PotenzaJeisys Medical, Inc.20241—
+10K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K240999Legend X Applicator VOPollogen, Ltd.20241—
+10K233849BTL-499BTL Industries, Inc.20240—
+10K233604BTL-785SBTL Industries, Inc.20243—
+10K234085LUNE™ PureHygieneEnamel Pure20241—
+10K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+10K230837PlazMagikAgnes Medical Co., Ltd.20240—
+10K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+10K232223PlaDuo SystemShenB Co., Ltd.20230—
+10K230167BACK 4Swims America Corp20230—
+10K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+10K230037BACK 3Swims America Corp20230—
+10K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+10K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V.202310—
+10K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+10K212472AgeJetTriworks Group Srl20220—
+10K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+10K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+10K211681EONDominion Aesthetic Technologies, Inc.20221—
+10K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+10K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+10K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—