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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 radiofrequency coagulation device for wrinkle reduction
Definition An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.
Product CodePAY
Regulation Number 878.4420
Device Class 2


Premarket Reviews
ManufacturerDecision
EL GLOBAL TRADE LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOREO, INC.
  SUBSTANTIALLY EQUIVALENT 1
POLLOGEN LTD.
  SUBSTANTIALLY EQUIVALENT 3
SILK'N BEAUTY LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 2 2
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Product Quality Problem 1 1
Patient-Device Incompatibility 1 1
Device Markings/Labelling Problem 1 1
Packaging Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Erythema 2 2
Skin Discoloration 2 2
Swelling/ Edema 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Headache 1 1
Itching Sensation 1 1
Undesired Nerve Stimulation 1 1
Pain 1 1

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