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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
GLOBALMED TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
HEAT IN A CLICK LLC
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON CONSUMER INC.
  SUBSTANTIALLY EQUIVALENT 1
LED TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
LI-TEK ELECTRONIC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LI-TEK ELECTRONICS TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
MEDTEK SKINCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
MZ SKIN
  SUBSTANTIALLY EQUIVALENT 1
OMM IMPORTS, INC. D/B/A ZERO GRAVITY
  SUBSTANTIALLY EQUIVALENT 1
ORIENTAL INSPIRATION LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PULSADERM LLC
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN KAIYAN MEDICAL CO LTD
  SUBSTANTIALLY EQUIVALENT 2
UPLEVITY, INC.
  SUBSTANTIALLY EQUIVALENT 1
UVBIOTEK, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 7 7
2019 19 19
2020 8 8
2021 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 37 37
Temperature Problem 2 2
Smoking 2 2
Battery Problem 1 1
Overheating of Device 1 1
Noise, Audible 1 1
Explosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 12 12
Visual Impairment 10 10
Headache 9 9
Burn(s) 5 5
Reaction 4 4
Skin Irritation 3 3
Loss of Vision 3 3
Pain 3 3
Swelling 2 2
Seizures 2 2
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
Swelling/ Edema 1 1
Tissue Damage 1 1
Dry Eye(s) 1 1
Eye Injury 1 1
Visual Disturbances 1 1
Dizziness 1 1
Peeling 1 1
Scar Tissue 1 1
Scarring 1 1
Unspecified Infection 1 1
Irritation 1 1
Laceration(s) 1 1
Miscarriage 1 1
Optical Nerve Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Accord Media, LLC II Mar-01-2018
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