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
+10K240969IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)Shenzhen Semlamp Intelligent Technology Co., Ltd.20240—
+10K240264Home Use Hair Removal Device (Model (s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A…Shenzhen Mlay Intelligent Technology Co.,, Ltd.20246—
+10K232846Light Based Hair Removal DeviceShenzhen Meik Beauty Industry Co., Ltd.20230—
+10K232932Intense Pulse Light Therapeutic ApparatusShenzhen Greatro Electronic Technology Co., Ltd.20235—
+10K232845IPL Cooling Hair Removal DeviceShenzhen Siken 3D Technology Development Co., Ltd.20230—
+10K230167BACK 4Swims America Corp20230—
+10K230037BACK 3Swims America Corp20230—
+10K230549IPL Hair Removal Device, Model (s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG…Shenzhen Xiazhifeng Electronic Co., Ltd.20230—
+10K223928Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E…Shenzhen Fansizhe Science and Technology Co., Ltd.202312—
+10K213889PicoStarAsclepion Laser Technologies GmbH20220—
+10K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+11K250131IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011…Mustech Electronics Co., Limited20250—
+11K242595Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)Shenzhen Greatro Electronic Technology Co., Ltd.20243—
+11K232575Hair Removal Device, Model (s): R2815-G Pro, R2815-GShenzhen Jianchao Intelligent Technology Co., Ltd.20235—
+11K231613Intense pulsed light device, Model (s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B…Zhuzhou Goldenhot Medical Technology Co., Ltd.20238—
+11K202503ChromeQuanta System Spa202012—
+12K262524Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B…ONE BEAUTY Technology Co., Ltd.20260—
+12K253765Vanish ProDdc Technologies, Inc.20260—
+12K251707IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)Shenzhen Huachuangtong Industrial Co., Ltd.20250—
+12K250281Deka LotusEl.En S.P.A.20250—
+12K241527Pastelle ProWontech Co., Ltd.20253—
+12K241120Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06…Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd.20241—
+12K233473Deka LotusEl.En S.P.A.20241—
+12K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+12K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+12K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+13K252234IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16…Shenzhen Qiaochengli Technology Co., Ltd.20250—
+13K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—