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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device light based over-the-counter hair removal
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Definition Over-the-counter device uses thermal energy to kill hair follicles for hair removal.
Product CodeOHT
Regulation Number 878.4810
Device Class 2


Premarket Reviews
ManufacturerDecision
CYDEN LIMITED
  SUBSTANTIALLY EQUIVALENT 7
DONGGUAN BOYUAN INTELLIGENT TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN DEFINE BEAUTY ELECTRONIC TECHNOLOGY CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN LIDE ELECTRIC APPLIANCE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
FOREO INC.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN JINDI ELECTRIC APPLIANCE CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
GLAN ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU HAOXINGWAN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN GUANGYE BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ILUMINAGE BEAUTY CO., LIMITED
  SUBSTANTIALLY EQUIVALENT 1
IVYLASER (BEIJING) TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KAM YUEN PLASTIC PRODUCTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
LUMENESSA CORP
  SUBSTANTIALLY EQUIVALENT 1
MILEY TECHNOLOGY(HEBEI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MORLASER SHENZHEN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
QIAOCHENG LI (DONGGUAN) MEDICAL INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BEAUTY EVERY MOMENT INTELLIGENT ELECTRIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN BEAUTY EVERY MOMENT INTELLIGENT ELECTRIC CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN BORRIA TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BORRIA TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BSX TECHNOLOGY ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CENTURY DONGYUAN TECHNOLOGY CO LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN DESIDA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN FANSIZHE SCIENCE AND TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN GOODWIND TECHNOLOGY DEVELOPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN GREATRO ELECTRONIC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN GREATRO ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN GSD TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HUARUIBO ELECTRIC APPLIANCES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN IONKA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ISHINE TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JIANCHAO INTELLIGENT TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN JIANRONG BIOMEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JIZHIMEI TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JUNBOBEAUTY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JUNMEI TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN KOLI TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN LEAFLIFE TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN LESCOLTON ELECTRICAL APPLIANCE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN LESCOLTON ELECTRICAL APPLIANCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN LIZBELLA TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MAREAL TECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MEIK BEAUTY INDUSTRY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MISMON TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MYWIN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN NOBLE SMART MANUFACTURING TECH CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN QIANYU TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN QIAOCHENGLI TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN SEMLAMP INTELLIGENT TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN SHUGE MEDICAL BEAUTY DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN SIKEN 3D TECHNOLOGY DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN ULIKE SMART ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN ULIKE SMART ELECTRONICS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 6
SHENZHEN ULIKE SMART ELECTRONICS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN WEIKAI TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN WOCHUAN ELECTRONIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN XIAZHIFENG ELECTRONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN YANG WO ELECTRONIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN YANGYI TECHNOLOGY ., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN YUWEI ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MLAY INTELLIGENT TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ULIKE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ULIKE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUHAN LOTUXS TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHONGSHAN BISEN PLASTIC ELECTRONIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHONGSHAN QIZHE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHUZHOU GOLDENHOT MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHUZHOU GOLDENHOT MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 3 3
2021 1 1
2022 2 2
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Device Operational Issue 2 2
Use of Device Problem 2 2
Energy Output Problem 2 2
Patient-Device Incompatibility 1 1
Product Quality Problem 1 1
Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Rash 4 4
Skin Inflammation/ Irritation 2 2
Itching Sensation 2 2
Erythema 2 2
Superficial (First Degree) Burn 2 2
Vitreous Floaters 1 1
Reaction 1 1
Blurred Vision 1 1
Partial thickness (Second Degree) Burn 1 1
Swelling/ Edema 1 1
Radiation Exposure, Unintended 1 1
Pain 1 1
Burning Sensation 1 1
Scar Tissue 1 1
Impaired Healing 1 1

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