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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device over-the-counter powered light based laser for acne
Definition The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris. The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.
Product CodeOLP
Regulation Number 878.4810
Device Class 2


Premarket Reviews
ManufacturerDecision
BEIJING ADSS DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN HUNTER ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GLOBALMED TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
HARPAR GRACE INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
HEAT IN A CLICK LLC
  SUBSTANTIALLY EQUIVALENT 1
LED TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
LI-TEK ELECTRONICS TECHNOLOGY C0., LTD
  SUBSTANTIALLY EQUIVALENT 1
LIGHT TREE VENTURES EUROPE B.V.
  SUBSTANTIALLY EQUIVALENT 1
LUMINANCE MEDICAL VENTURES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MARCI BEAUTY INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTEK SKINCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
MZ SKIN
  SUBSTANTIALLY EQUIVALENT 1
PREMIER NORTH AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN KAIYAN MEDICAL CO LTD
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 19 19
2020 8 8
2021 7 7
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 31 31
Temperature Problem 3 3
Smoking 2 2
Battery Problem 1 1
Noise, Audible 1 1
Explosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 11 11
Headache 10 10
Visual Impairment 8 8
Reaction 4 4
Burn(s) 2 2
Loss of Vision 2 2
Pain 2 2
Peeling 1 1
Scar Tissue 1 1
Scarring 1 1
Seizures 1 1
Skin Discoloration 1 1
Skin Irritation 1 1
Swelling 1 1
Tissue Damage 1 1
Blurred Vision 1 1
Visual Disturbances 1 1
Dizziness 1 1
Unspecified Infection 1 1
Irritation 1 1
Laceration(s) 1 1
Optical Nerve Damage 1 1
Dry Eye(s) 1 1
Eye Injury 1 1
Burn, Thermal 1 1
No Known Impact Or Consequence To Patient 1 1
Not Applicable 1 1
No Information 1 1
Unspecified Eye / Vision Problem 1 1
Muscle/Tendon Damage 1 1
Increased Sensitivity 1 1
Skin Inflammation/ Irritation 1 1
Swelling/ Edema 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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