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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
ALMA LASERS INC.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING ADSS DEVELOPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BEIJING GLOBALIPL DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING SUPERLASER TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
E-SWIN
  SUBSTANTIALLY EQUIVALENT 1
FORMATK SYSTEMS LTD.
  SUBSTANTIALLY EQUIVALENT 1
IDS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
LUVO MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGDONG HUAMEI TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BOYUAN INTELLIGENT ELECTRONIC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD
  SUBSTANTIALLY EQUIVALENT 1
VENUS CONCEPT LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 6 6
2017 1 1
2018 1 1
2019 2 2
2020 1 1
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Use of Device Problem 3 3
Insufficient Information 3 3
Incorrect Software Programming Calculations 1 1
Patient-Device Incompatibility 1 1
Device Operates Differently Than Expected 1 1
Programming Issue 1 1
Electrical /Electronic Property Problem 1 1
Application Program Problem: Parameter Calculation Error 1 1
Device Inoperable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 8 8
Partial thickness (Second Degree) Burn 7 7
Burn, Thermal 7 7
Pain 2 2
Vomiting 1 1
Burning Sensation 1 1
Hot Flashes/Flushes 1 1
Bacterial Infection 1 1
Eye Injury 1 1
Hair Loss 1 1
Headache 1 1
Hemorrhage, Subdural 1 1
Nerve Damage 1 1
Hematoma 1 1
Retinal Injury 1 1
Swelling 1 1
Discharge 1 1
Ulcer 1 1

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