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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device light based over-the-counter hair removal
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
CONAIR CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CYDEN LIMITED
  SUBSTANTIALLY EQUIVALENT 7
DONGGUAN DEFINE BEAUTY ELECTRONIC TECHNOLOGY CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
EL GLOBAL TRADE LTD
  SUBSTANTIALLY EQUIVALENT 1
EL GLOBAL TRADE LTD.
  SUBSTANTIALLY EQUIVALENT 1
GLAN ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU HAOXINGWAN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOME SKINOVATIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOME WELL TRADING LTD
  SUBSTANTIALLY EQUIVALENT 2
ILUMINAGE BEAUTY CO., LIMITED
  SUBSTANTIALLY EQUIVALENT 1
KAM YUEN PLASTIC PRODUCTS LTD
  SUBSTANTIALLY EQUIVALENT 1
LIAONING SIDEY OPTOELECTRONICS TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL DEVICE BRANCH OF ZHANGZHOU EASEPAL INDUSTRIAL CO.,LT
  SUBSTANTIALLY EQUIVALENT 1
ORIENTAL INSPIRATION LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SHEN ZHEN COSBEAUTY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHEN ZHEN COSBEAUTY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BEAUTY EVERY MOMENT INTELLIGENT ELECTRIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BEAUTY EVERY MOMENT INTELLIGENT ELECTRIC CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN BORRIA TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BOSIDIN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CENTURY DONGYUAN TECHNOLOGY CO LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN FANSIZHE SCIENCE AND TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN GSD TECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JUNBOBEAUTY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN LEAFLIFE TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MAREAL TECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MISMON TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MISMON TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN QIANYU TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN QIAOCHENGLI TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN WEIKAI TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN YUWEI ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHONGSHAN BISEN PLASTIC ELECTRONIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 3 3
2021 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Patient-Device Incompatibility 2 2
Device Operational Issue 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 1 1
Erythema 1 1
Itching Sensation 1 1
Pain 1 1
Rash 1 1
Scar Tissue 1 1
Reaction 1 1
Burn, Thermal 1 1
Radiation Exposure, Unintended 1 1
Skin Inflammation/ Irritation 1 1

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