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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
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
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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 15 15
Noise, Audible 1 1
Explosion 1 1
Temperature Problem 1 1

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

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