Cleared Special

Geneo X Elite

K233766 · Pollogen, Ltd. · General & Plastic Surgery
May 2024
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K233766 is an FDA 510(k) clearance for the Geneo X Elite, a Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction (Class II — Special Controls, product code PAY), submitted by Pollogen, Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on May 7, 2024, 165 days after receiving the submission on November 24, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4420.

Submission Details

510(k) Number K233766 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2023
Decision Date May 07, 2024
Days to Decision 165 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

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.