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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device powered light based non-laser surgical instrument with thermal effect
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Definition A light based non-laser device that provides thermal effect including broad spectrum source devices such as intense pulse light (ipl). Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic. Indication for use can be general and/or specific.The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, or remove tissue by the light.
Product CodeONF
Regulation Number 878.4810
Device Class 2


Premarket Reviews
ManufacturerDecision
BEIJING ADSS DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING GLOBALIPL DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
E-SWIN
  SUBSTANTIALLY EQUIVALENT 1
EL.EN S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
EL.EN. S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU CIELLULU PHOTOELECTRIC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HEBEI ZHEMAI TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
KAM YUEN PLASTIC PRODUCTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
LUVO MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NANJING BESTVIEW LASER S&T CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGDONG HUAMEI TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI OMNI LASER SKINOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ACCOMPANY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BOYUAN INTELLIGENT ELECTRONIC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN IONKA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MYWIN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMEDTRUM MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TENTECH CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
ULIKE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
VENUS CONCEPT INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 2 2
2022 2 2
2023 3 3
2024 3 3
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Insufficient Information 2 2
Electrical /Electronic Property Problem 2 2
Inadequate Instructions for Non-Healthcare Professional 1 1
Patient-Device Incompatibility 1 1
Use of Device Problem 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Discoloration 2 2
Burn(s) 2 2
Burning Sensation 2 2
Pain 2 2
Scar Tissue 2 2
Full thickness (Third Degree) Burn 2 2
Emotional Changes 1 1
Skin Inflammation/ Irritation 1 1
Hematoma 1 1
Muscle Weakness 1 1
Erythema 1 1
Vomiting 1 1
Discomfort 1 1
Depression 1 1
Anxiety 1 1
Swelling/ Edema 1 1
Ulcer 1 1
Partial thickness (Second Degree) Burn 1 1
Physical Asymmetry 1 1
Bacterial Infection 1 1
Headache 1 1
Deformity/ Disfigurement 1 1
Neuralgia 1 1
Distress 1 1

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