510(k) Report

Devices descending from K003614

728 later devices reach Lightsheer Pulsed Diode Array Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+8K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+8K243465Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device…Guangzhou Chuang Zao Mei Technology Co., Ltd.20250—
+8K243139Reverso Pro SystemIndiba S. A. U.20250—
+8K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+8K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+8K241498Diode laser Treatment System (K18)Hebei Keylaser Sci-Tech Co.,Ltd20240—
+8K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+8K242039Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)Shenzhen Ulike Smart Electronics Co., Ltd.202413—
+8K242197IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)Shenzhen Huaruibo Electric Appliances Co., Ltd.20240—
+8K241834IPL Hair Removal Device (BE932C, BE932D, BE932E)Shenzhen Yang WO Electronic Co., Ltd.20242—
+8K241205Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S…Shenzhen Ulike Smart Electronics Co., Ltd.20242—
+8K240016IPL Hair Removal Device (YT01,YT02,YT03,YT04)Shenzhen Jianrong Biomedical Electronics Co., Ltd.20249—
+8K241343IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A…Shenzhen Lescolton Electrical Appliance Co., Ltd.20241—
+8K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+8K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+8K240583IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W…Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20240—
+8K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+8K241106Ice Cooling IPL Home Use Hair Removal Device (Model (s): T10B, T10C, T15A, T17A, T18A…Shenzhen Mlay Intelligent Technology Co.,, Ltd.20242—
+8K240752Deka ToroEl.En S.P.A.20240—
+8K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+8K240093IPL Home Use Hair Removal Device (SJ15)Shenzhen Shuge Medical Beauty Devices Co., Ltd.20240—
+8K234085LUNE™ PureHygieneEnamel Pure20241—
+8K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+8K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+8K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+8K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+8K232056IPL Hair Removal Device, Model (s): PB1, PB2, PB3, PB4, TM002Dongguan Lide Electric Appliance Co., Ltd.20230—
+8K232124IPL Hair Removal, Model: W-1095, W-1098Shenzhen Wochuan Electronic Co., Ltd.20230—
+8K231800IPL Hair Removal Device, Model (s): JP1, JR3, JR8, JR9Shenzhen Qianyu Technology Co., Ltd.20231—
+8K231215IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008SZhongshan Qizhe Technology Co., Ltd.20230—
+8K230739Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd.202311—
+8K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+8K230360IPL Cooling Hair Removal Device, Model (s): NBB01, NBB02Shenzhen Jizhimei Technology Co., Ltd.202317—
+8K230021IPL Hair Removal Device, Model (s): AP10, AP20, AP30, AP32Shenzhen Yangyi Technology ., Ltd.20236—
+8K230060Light Based Hair Removal Device GP592Shenzhen Gsd Tech Co., Ltd.20230—
+8K223524IPL Hair Removal, Model (s): SB01, SB01A, SB01B, SB01C, SN02, SN03Morlaser Shenzhen Co., Ltd.20230—
+8K222537IPL Hair Removal Device, Model (s): skn001,skn005,skn006,skn002,RoseSkinCo LumiShenzhen Ishine Technology Company Limited202211—
+8K221553Diamond Air+ (UI04A, UI04B, UI04C)Ulike Co., Ltd.20221—
+8K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+8K221451IPL hair removalShenzhen Lizbella Technology Co.,Ltd20220—
+8K221246IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)Shenzhen Semlamp Intelligent Technology Co., Ltd.20220—
+8K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+8K221001IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20226—
+8K213830Home use hair removal device, model: Precise Touch ProIluminage Beauty Co., Limited20220—
+8K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+8K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+8K212897IPL Hair Removal Device, model: AI01Shenzhen Century Dongyuan Technology CO, Ltd.20211—
+8K212314IPL Hair Removal DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.202123—
+8K210376Superior Hair RemoverGuangzhou Haoxingwan Technology Co., Ltd.20210—
+8K211922IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20210—
+8K210311Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6…Shenzhen Mismon Technology Co., Ltd.202124—
+8K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+8K183450EmBody SystemInmode MD, Ltd.20198—
+8K181568IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt201888—
+8K172771Epic Pro 940Biolase, Inc.20171—
+8K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+8K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+8K141583Shaser Skin Beauty Intense Pulsed Light System FamilyShaser, Inc.20142—
+8K140631Lumena FH Hair Removal SystemShaser, Inc.201495—
+9K260138LUNE PureHygieneEnamel Pure20260—
+9K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+9K252048808nm semiconductor laser hair removal machineXi'An Taibo Electronic Technology Co., Ltd.20260—
+9K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+9K253007Laser 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—
+9K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+9K251914IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal…Miley Technology (Hebei) Co., Ltd.20250—
+9K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K251000Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)Shenzhen Chuangtong Yigou Technology Co., Ltd.20251—
+9K243036IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B…Bestway Plastic and Metal Products, Ltd.20251—
+9K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+9K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+9K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+9K243085IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V…Zhuzhou Goldenhot Medical Technology Co., Ltd.20240—
+9K243030Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)Ulike Co., Ltd.20240—
+9K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+9K241881IPL Hair Removal Device (JM-843, JM-865, JM-638)Shenzhen Junmei Technology Co., Ltd.20241—
+9K232499IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)Shenzhen Lescolton Electrical Appliance Co., Ltd.20234—
+9K232183IPL Hair Removal Device, Model (s): T1, T2, T3, T7, T10Shenzhen Koli Technology Co.,Ltd20230—
+9K230097IPL Hair Removal Device, Model (s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108Shenzhen Bsx Technology Electronics Co., Ltd.20238—
+9K222710IPL Cooling Hair Removal DeviceShenzhen Siken 3D Technology Development Co., Ltd.20220—
+9K222432IPL Hair Removal Device, Model (s): KCA423, KCA437, KCA439Hunan Guangye Biotechnology Co., Ltd.20220—
+9K222316IPL Hair Removal DeviceShenzhen Goodwind Technology Development Co., Ltd.20221—
+9K221466IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17Shenzhen Century Dongyuan Technology CO, Ltd.20220—
+9K220248Home use hair removal deviceShenzhen Mareal Tech Co., Ltd.20228—
+9K220669IPL HAIR REMOVAL HANDSET, Model: IPL-666Shenzhen Junbobeauty Technology Co., Ltd.20222—
+9K220222IPL Hair Removal Device, model (s): S1-A, S2-A, S1, S2, S3, S4Shenzhen Yuwei Electronic Technology Co., Ltd.202213—
+9K212318IPL Hair RemovalDongguan Define Beauty Electronic Technology Co., Ltd.202226—
+9K213020IPL hair removal machineShenzhen Borria Technology Co., Ltd.20210—
+9K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+9K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+9K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+9K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+9K142924Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System FamilyShaser, Inc.20150—
+10K261701Hemolase 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—
+10K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+10K260594IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP…Shenzhen Xiazhifeng Electronic Co., Ltd.20260—
+10K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+10K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+10K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—