Cleared Traditional

FAQ? (102)

K240616 · Foreo, Inc. · Physical Medicine
Jul 2024
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K240616 is an FDA 510(k) clearance for the FAQ? (102), a Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction (Class II — Special Controls, product code PAY), submitted by Foreo, Inc. (Las Vegas, US). The FDA issued a Cleared decision on July 15, 2024, 132 days after receiving the submission on March 5, 2024. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 878.4420.

Submission Details

510(k) Number K240616 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2024
Decision Date July 15, 2024
Days to Decision 132 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code PAY — Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4420
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.