510(k) Report

Devices descending from K024093

756 later devices reach Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+8K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.20250—
+8K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd.20253—
+8K242638LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.20241—
+8K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+8K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+8K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+8K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+8K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+8K241102Luna 4 plusForeo, Inc.20245—
+8K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+8K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+8K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+8K240752Deka ToroEl.En S.P.A.20240—
+8K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+8K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+8K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+8K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+8K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.20242—
+8K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+8K233224Epilaser ProEpilady 2000, LLC20240—
+8K232106Air Gap FiberWontech Co., Ltd.20240—
+8K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+8K232708Intense pulsed light therapy deviceHebei Zhemai Technology Co., Ltd.20230—
+8K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+8K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+8K222556BTL-785XBTL Industries, Inc.20235—
+8K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+8K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+8K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+8K210084SilkroHironic Co., Ltd.20223—
+8K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+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—
+8K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+8K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+8K201685PotenzaJeisys Medical, Inc.20219—
+8K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+8K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+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—
+8K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+8K193486Epic 980Biolase, Inc.20202—
+8K200234Surgical laser fibersQuanta System Spa20202—
+8K191086ExciplexClarteis20194—
+8K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+8K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+8K183450EmBody SystemInmode MD, Ltd.20198—
+8K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K180044SIROLaser BlueDentsply Sirona201812—
+8K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+8K163197Cook Holmium Laser FiberCook Incorporated20170—
+8K163128Epic ProBiolase, Inc.201716—
+8K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+8K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+8K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+8K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+9K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+9K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+9K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.20260—
+9K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.20260—
+9K260150Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)Nooance20260—
+9K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+9K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+9K253712LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063…Shenzhen Rainbow Technology Co., Ltd.20261—
+9K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.20250—
+9K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+9K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd.20252—
+9K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+9K252093Light Therapy Mask (1019055)Merchsource, LLC20250—
+9K250880Led Light Mask (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd.20250—
+9K250581KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+9K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+9K244020Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd.20250—
+9K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+9K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+9K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+9K242688Finiff SystemSkingrab Co., Ltd.20240—
+9K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+9K231216PotenzaJeisys Medical, Inc.20244—
+9K231287PotenzaJeisys Medical, Inc.20241—
+9K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+9K233123SilkroHironic Co., Ltd.20241—
+9K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+9K233099GladiatorRohrer Aesthetics, LLC20240—
+9K240999Legend X Applicator VOPollogen, Ltd.20241—
+9K233849BTL-499BTL Industries, Inc.20240—
+9K233604BTL-785SBTL Industries, Inc.20243—
+9K234085LUNE™ PureHygieneEnamel Pure20241—
+9K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+9K230837PlazMagikAgnes Medical Co., Ltd.20240—
+9K233143PiXel8-RevealRohrer Aesthetics20240—
+9K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+9K233147PiXel8-RFRohrer Aesthetics20230—
+9K232223PlaDuo SystemShenB Co., Ltd.20230—