FDA 510(k) Applications Submitted by Yang Yang

FDA 510(k) Number Submission Date Device Name Applicant
K211361 05/03/2021 3N Contact Lenses Adjunct Cleaner Suzhou 3N Biological Technology Co., Ltd
K233036 09/25/2023 Ultrasonic Surgical System Hunan Handlike Minimally Invasive Surgery Co., Ltd.
K250194 01/23/2025 Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH) Shenzhen Ulike Smart Electronics Co.,Ltd.
K241205 04/30/2024 Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE) Shenzhen Ulike Smart Electronics Co., Ltd.
K251984 06/27/2025 Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) Shenzhen Ulike Smart Electronics Co.,Ltd.
K241998 07/09/2024 Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP) Shenzhen Ulike Smart Electronics Co., Ltd.
K242039 07/12/2024 Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR) Shenzhen Ulike Smart Electronics Co.,Ltd.
K243749 12/05/2024 Jmoon Conductive Gel Shenzhen Ulike Smart Electronics Co., Ltd.
K213947 12/17/2021 Ultrasonic Endo Activation Device (Model:Actor I pro) ChangZhou BoMedent Medical Technology Co.,Ltd
K222907 09/26/2022 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate RMKH Glove (Cambodia) Co., Ltd.
K230277 02/01/2023 Pulse Oximeter(Model OHT60,OXH78) Cofoe Medical Technology Co., Ltd.
K212092 07/06/2021 Portable Folding Electric Wheelchair (Model: DC01) Anhui JBH Medical Apparatus Co., Ltd
K170965 03/31/2017 Fingertip Pulse Oximeter Shenzhen Jumper Medical Equipment Co., Ltd.
K211750 06/07/2021 Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) National Bridge Industrial (S.Z.) Co., Ltd.
K210475 02/17/2021 EQ-M Meta Systems Co., Ltd
K141874 07/11/2014 URISCAN OPTIMA YD DIAGNOSTICS CORP.
K132313 07/25/2013 PESSARY EIS CORPORATION
K102188 08/03/2010 CYBOW READER, MODELS 300 & 720 DFI CO., LTD.
K192048 07/31/2019 Single Use Endoscope Valves Set Anrei Medical (Hangzhou) Co., Ltd.
K170545 02/24/2017 Automatic Wrist Bluetooth Blood Pressure Monitor Truly Instrument Ltd.
K090564 03/02/2009 TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370 TRULY INSTRUMENT LIMITED
K091415 05/13/2009 TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702M TRULY INSTRUMENT CO., LTD.
K161846 07/05/2016 Automatic Arm Bluetooth Blood Pressure Monitor TRULY INSTRUMENT LIMITED
K081852 06/30/2008 TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11 TRULY INSTRUMENT LIMITED
K223709 12/12/2022 Kyphoplasty Balloon Catheter Jiangsu Changmei Medtech Co., Ltd.
K240081 01/11/2024 Human Lubricant Jiangxi Wulinxiang Biological Technology Co., Ltd.
K171889 06/26/2017 Reusable Blood Pressure Cuff Suzhou Minhua Medical Apparatus Supplies Co., LTD
K210578 02/26/2021 Medical Nitrile Examination Gloves (Power free, Blue) Jiangxi Hongda Medical Equipment Group Ltd.
K210821 03/19/2021 Medical PVC Examination Gloves Jiangxi Hongda Medical Equipment Group Ltd.
K002727 08/31/2000 YOUNG-HEALTH SUPER EAR THERMOMETER YOUNG HEALTH IND. CO., LTD.
K170281 01/30/2017 MSA100BT Peak Flow Meter Beijing M&B Electronic Instruments Co., Ltd.
K180983 04/13/2018 Maxcon Two Gallon Chemotherapy Container Ningbo Maxcon Medical Technology Co., Ltd.
K180984 04/13/2018 Maxcon Sharps Container Ningbo Maxcon Medical Technology Co., Ltd.
K203410 11/19/2020 ENFit Disposable Enteral Syringe Shantou Wealy Medical Instrument Co., Ltd.
K203613 12/10/2020 ENFit Reusable Enteral Syringe Shantou Wealy Medical Instrument Co., Ltd.
K151936 07/14/2015 Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle SYNAPTIC MEDICAL LIMITED
K011913 06/19/2001 SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES SUN-RAIN SYSTEM CORP.
K012796 08/21/2001 AMLUCK AUTOMATIC DIGITAL WRIST, BLOOD PRESSURE MONITOR AK-3000/AK-4000 AMLUCK, INC.
K121527 05/23/2012 WI-FI BODY SCALE SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD
K203685 12/17/2020 Disposable Surgical Face Mask Xiantao Zhongyi Safety & Protection Products Co., Ltd
K163161 11/10/2016 Sterile Single-use Syringe with Needle JiangXi HongDa Medical Equipment Group Ltd.
K163162 11/10/2016 Sterile Hypodermic Safety Syringes for Single Use JiangXi HongDa Medical Equipment Group Ltd.
K250350 02/07/2025 Thrive 2-in-1 Breast Pump (Model P3) Shenzhen TPH Technology Co., Ltd.
K250463 02/18/2025 Ameda GLO Wearable Breast Pump (Model W8S) Shenzhen TPH Technology Co., Ltd.
K240729 03/18/2024 Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61) Shenzhen Pango Medical Electronics Co., Ltd.
K190397 02/19/2019 Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA Immunalysis Corporation
K210367 02/08/2021 D-Laser Blue, D-Laser 16 Guilin Woodpecker Medical Instrument Co., Ltd.
K211358 05/03/2021 Implanter incl. Accessories Guilin Woodpecker Medical Instrument Co., Ltd.
K240675 03/11/2024 Endoscopic Injection Needles Promisemed Hangzhou Meditech Co., Ltd.
K150204 01/29/2015 DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K170277 01/30/2017 DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K121010 04/03/2012 M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K180912 04/06/2018 TE7/TE5 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd
K171579 05/31/2017 M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd
K131690 06/10/2013 M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K122010 07/09/2012 Z6 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K152545 09/08/2015 DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K172970 09/26/2017 M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound ShenZhen Mindray Bio-Medical Electronics Co., Ltd
K173471 11/08/2017 DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Shenzhen Mindray Bio-medical Electronics Co., LTD
K143472 12/05/2014 TE7 Diagnostic Ultrasound System SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K163690 12/28/2016 DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K122393 08/07/2012 TG-BODY MI&BODY S-TRAINER MIGA MEDICAL CO., LTD.
K122410 08/08/2012 I RUNE (I-200L) MEDIRUNE CO, LTD
K230759 03/20/2023 SafeLan« (2 models/SafeLan 26G, SafeLan 30G), SafeLan«-Pro (1 model/SafeLan«-Pro) Bosungmeditech Co., Ltd.
K162259 08/11/2016 DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) ZIBO DAIYANG PLASTIC COMPANY
K211335 05/03/2021 Diode Laser Machine, Model Number: BM-100 Zhengzhou Bestview St Co., Ltd.
K211735 06/07/2021 CO2 Laser Machine, Model: BW-203B Zhengzhou Bestview St Co., Ltd.
K091434 05/13/2009 TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M TRULY INSTRUMENT CO., LTD.
K233401 10/04/2023 Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) Eieling Technology Limited
K083601 12/05/2008 LAMBDA LIGHT CHAINS SENTINEL CH. SpA
K083602 12/05/2008 KAPPA LIGHT CHAINS SENTINEL CH. SpA


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