510(k) K240616

FAQ (102) by Foreo, Inc. — Product Code PAY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 15, 2024
Date Received: March 5, 2024
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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