510(k) Report

Devices descending from K013623

856 later devices reach Clearlight Phototheraphy System, Model CL 420 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+8K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+8K220853PicoWay Laser SystemCandela Corporation20221—
+8K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+8K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+8K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.202241—
+8K210084SilkroHironic Co., Ltd.20223—
+8K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+8K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+8K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+8K212127PicocaremajestyWontech Co., Ltd.20226—
+8K201773PicohiHironic Co., Ltd.20215—
+8K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+8K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+8K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+8K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+8K201685PotenzaJeisys Medical, Inc.20219—
+8K201735PlaDuo SystemShenB Co., Ltd.20203—
+8K200693K2 MobileHulaser, Inc.20202—
+8K202041Opera EvoQuanta System Spa20200—
+8K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+8K200786Venus EpileveVenus Concept USA, Inc.20200—
+8K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+8K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+8K193486Epic 980Biolase, Inc.20202—
+8K200234Surgical laser fibersQuanta System Spa20202—
+8K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+8K191855EmFace DeviceInmode MD, Ltd.20191—
+8K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+8K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+8K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+8K181095RF-ReliefEl Global Trade, Ltd.20181—
+8K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K180044SIROLaser BlueDentsply Sirona201812—
+8K173677InMode VLazeInmode MD, Ltd.20183—
+8K172302InMode PLUS SystemInmode MD, Ltd.201713—
+8K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+8K163197Cook Holmium Laser FiberCook Incorporated20170—
+8K163128Epic ProBiolase, Inc.201716—
+8K163222Discovery Pico FamilyQuanta System Spa201630—
+8K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+8K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+8K153566Magma SystemFormatk Systems, Ltd.20162—
+8K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+8K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+8K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+9K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+9K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+9K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+9K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+9K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+9K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+9K252096Light Therapy Decollete Mask (1019135)Merchsource, LLC20250—
+9K250734OptiLUV DevicePollogen, Ltd.20250—
+9K250966CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+9K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+9K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+9K250809Stellar M22Lumenis Be, Ltd.20250—
+9K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+9K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+9K242688Finiff SystemSkingrab Co., Ltd.20240—
+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—
+9K231216PotenzaJeisys Medical, Inc.20244—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K231287PotenzaJeisys Medical, Inc.20241—
+9K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+9K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+9K233123SilkroHironic Co., Ltd.20241—
+9K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+9K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+9K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+9K233099GladiatorRohrer Aesthetics, LLC20240—
+9K240752Deka ToroEl.En S.P.A.20240—
+9K240999Legend X Applicator VOPollogen, Ltd.20241—
+9K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+9K233849BTL-499BTL Industries, Inc.20240—
+9K233604BTL-785SBTL Industries, Inc.20243—
+9K234085LUNE™ PureHygieneEnamel Pure20241—
+9K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+9K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+9K230837PlazMagikAgnes Medical Co., Ltd.20240—
+9K233143PiXel8-RevealRohrer Aesthetics20240—
+9K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+9K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+9K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+9K233147PiXel8-RFRohrer Aesthetics20230—
+9K232223PlaDuo SystemShenB Co., Ltd.20230—
+9K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+9K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+9K222790F65 Laser SystemLumenis Be, Ltd.20233—
+9K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+9K222221Deka HelixEl.En Electronic Engineering Spa20231—
+9K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+9K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+9K212472AgeJetTriworks Group Srl20220—
+9K211000AcutronIlooda Co,., Ltd.20220—
+9K220793InnoVoyce Laser FiberInnovoyce, LLC20220—