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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
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
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
ERCHONIA CORPORATION
  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 1
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
MZ SKIN
  SUBSTANTIALLY EQUIVALENT 1
NINGBO DECHANG ELECTRICAL MACHINERY MADE CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
PREMIER NORTH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN EYCO TECHNOLOGY CO., LTD.
  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
2020 8 8
2021 7 7
2022 1 1
2023 2 2
2024 1 1
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 15 15
Device Markings/Labelling Problem 1 1
Product Quality Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Explosion 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 5 5
Headache 5 5
No Code Available 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Skin Inflammation/ Irritation 2 2
Burn(s) 2 2
Dizziness 1 1
Dry Eye(s) 1 1
Optical Nerve Damage 1 1
Skin Discoloration 1 1
Irritation 1 1
Visual Disturbances 1 1
Swelling 1 1
Unspecified Eye / Vision Problem 1 1
Erythema 1 1
Discomfort 1 1
Pain 1 1
Scar Tissue 1 1
Laceration(s) 1 1
Muscle/Tendon Damage 1 1
Eye Injury 1 1
Swelling/ Edema 1 1
Tissue Damage 1 1
Blurred Vision 1 1
Increased Sensitivity 1 1

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