Cleared Traditional

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

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 115d · This submission: 261d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

BioVision , Ltd.
Elissa Burg

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.

Clinical Evidence

ClinicalTrials.gov
NCT01858415 Unknown Interventional Industry-sponsored

Evaluation of Safety and Efficacy of TriPollar Device for Treatment of Wrinkles

Evaluation of Safety and Efficacy of TriPollar Device for Treatment of Wrinkles and Rhytides

40
Patients (est.)
2
Sites
Treatment
Purpose
Open label
Masking
Condition studied Facial Wrinkles
Study design Single group
Eligibility All sexes · 35 Years+ · Healthy volunteers accepted
Principal investigator Mira Barki, PhD
Sponsor Pollogen (industry)
Started 2013-04-01 Primary completion 2013-12-01
Primary outcome
Safety of TriPollar
View full study on ClinicalTrials.gov