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510(k) K232424

CurrentBody Skin RF by El Global Trade, Ltd. — Product Code PAY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2024
Date Received
August 11, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Device Class
Class II
Regulation Number
878.4420
Review Panel
SU
Submission Type

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.

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