Cleared Special

K233766 - Geneo X Elite (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K233766 · Pollogen, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
165d
Days
Class 2
Risk

K233766 is an FDA 510(k) clearance for the Geneo X Elite. Classified as Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction (product code PAY), Class II - Special Controls.

Submitted by Pollogen, Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on May 7, 2024 after a review of 165 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4420 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pollogen, Ltd. devices

Submission Details

510(k) Number K233766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 114d · This submission: 165d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PAY Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

A. Stein Regulatory Affairs Consulting Company , Ltd.
Amit Goren

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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