Cleared Traditional

K182774 - STOP U (Packed Black USA), STOP U (Packed White USA) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182774 · Pollogen, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
261d
Days
Class 2
Risk

K182774 is an FDA 510(k) clearance for the STOP U (Packed Black USA), STOP U (Packed White USA). 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 June 19, 2019 after a review of 261 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Pollogen, Ltd. devices

Submission Details

510(k) Number K182774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2018
Decision Date June 19, 2019
Days to Decision 261 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 114d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - PAY Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction

All 11
Devices cleared under the same product code (PAY) and FDA review panel - the closest regulatory comparables to K182774.
Sensilift Pro (ST300XXYYZZZ)
K250341 · El Global Trade, Ltd. · Jan 2026
GENEO X ELITE
K242227 · Pollogen, Ltd. · Oct 2025
FAQ™ (102)
K240616 · Foreo, Inc. · Jul 2024
Geneo X Elite
K233766 · Pollogen, Ltd. · May 2024
CurrentBody Skin RF
K232424 · El Global Trade, Ltd. · Mar 2024
Silk'n Titan Allways
K230013 · Silk'N Beauty , Ltd. · Aug 2023