Cleared Traditional

FAQ 101

K222012 · Foreo, Inc. · General & Plastic Surgery

Apr 2023

Decision

271d

Days

Class 2

Risk

About This 510(k) Submission

K222012 is an FDA 510(k) clearance for the FAQ 101, 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 April 5, 2023, 271 days after receiving the submission on July 8, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4420.

Submission Details

510(k) Number	K222012 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 08, 2022
Decision Date	April 05, 2023
Days to Decision	271 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
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.