inforMED
PAYClass II

Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction

General, Plastic Surgery · 21 CFR 878.4420

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.

MDR events5All time
Recalls0All time
Registered firms36Currently listed
510(k) clearances12All time

Recent MDR events

5 adverse event reports on file

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Event type breakdown

Injury5

Most-reported manufacturers

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Medicube1Pollogen Ltd.1Shenzhen Shishibang Technology Co., Ltd.1Unknown1Voupre1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

36 firms currently registered for this product code

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510(k) clearances

12 clearances for this product code

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