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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 wrinkle reduction
Definition Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.
Product CodeOHS
Regulation Number 878.4810
Device Class 2


Premarket Reviews
ManufacturerDecision
AESTHETIC TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEMER INT. AG
  SUBSTANTIALLY EQUIVALENT 1
CAREWEAR CORP.
  SUBSTANTIALLY EQUIVALENT 1
CAROL COLE COMPANY DBA NUFACE
  SUBSTANTIALLY EQUIVALENT 1
CELLRETURN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DERMAL PHOTONICS CORP
  SUBSTANTIALLY EQUIVALENT 1
DUPLEX INTERNATIONAL TRADING LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FOREO INC.
  SUBSTANTIALLY EQUIVALENT 1
GALACTIC BEAUTY, LLC
  SUBSTANTIALLY EQUIVALENT 1
GTG WELLNESS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG NEWDERMO BIOTECH CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
HUNAN GUANGYE BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ISMART DEVELOPMENTS LTD
  SUBSTANTIALLY EQUIVALENT 1
ISMART MARKETING SVCS LTD
  SUBSTANTIALLY EQUIVALENT 1
LED INTELLECTUAL PROPERTIES LLC
  SUBSTANTIALLY EQUIVALENT 1
LED TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
LG ELECTRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIGHT TREE VENTURES EUROPE B.V.
  SUBSTANTIALLY EQUIVALENT 6
LYMA LIFE LTD.
  SUBSTANTIALLY EQUIVALENT 1
MYBLEND
  SUBSTANTIALLY EQUIVALENT 1
NINGBO HESI ELECTRIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
PREMIER NORTH AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN IDEA LIGHT LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN KAIYAN MEDICAL CO LTD
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN QIANYU TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN SUNGPO HI-TECH ELECTRONIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
STG24 CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
THERABODY, INC.
  SUBSTANTIALLY EQUIVALENT 1
THERAGUN, INC.
  SUBSTANTIALLY EQUIVALENT 1
Y & J BIO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
Y&J BIO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YRS GROUP INC
  SUBSTANTIALLY EQUIVALENT 1
YRS GROUP INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 2 2
2021 2 2
2022 2 2
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Therapeutic or Diagnostic Output Failure 1 1
Patient Device Interaction Problem 1 1
Failure to Charge 1 1
Failure to Power Up 1 1
Product Quality Problem 1 1
Inadequate or Insufficient Training 1 1
Use of Device Problem 1 1
Defective Component 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Erythema 3 3
Insufficient Information 3 3
Hypersensitivity/Allergic reaction 2 2
Pain 1 1
Rash 1 1
Scar Tissue 1 1
Skin Discoloration 1 1
Blurred Vision 1 1
Loss of Vision 1 1
Reaction 1 1
Eye Burn 1 1
Superficial (First Degree) Burn 1 1
Blister 1 1
Headache 1 1

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