Cleared Traditional

K250341 - Sensilift Pro (ST300XXYYZZZ)

K250341 is an FDA 510(k) clearance for Sensilift Pro (ST300XXYYZZZ), manufactured by El Global Trade, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code PAY cleared through the Traditional 510(k) pathway after a 334-day FDA review.

K250341 · El Global Trade, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
334d
Days
Class 2
Risk

K250341 is an FDA 510(k) clearance for the Sensilift Pro (ST300XXYYZZZ). Classified as Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction (product code PAY), Class II - Special Controls.

Submitted by El Global Trade, Ltd. (Netanya, IL). The FDA issued a Cleared decision on January 6, 2026 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 El Global Trade, Ltd. devices

FDA 510(k) Submission Details - K250341

510(k) Number K250341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2025
Decision Date January 06, 2026
Days to Decision 334 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
219d slower than avg
Panel avg: 115d · This submission: 334d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PAY Device Classification - Class 2, Special Controls

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 9
Devices cleared under the same product code (PAY) and FDA review panel - the closest regulatory comparables to K250341.
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
Pollogen STOP U Model UXV Device
K220322 · Pollogen, Ltd. · May 2023