Cleared Traditional

K250341 - Sensilift Pro (ST300XXYYZZZ) (FDA 510(k) Clearance)

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

K250341 · El Global Trade, Ltd. · General & Plastic Surgery device
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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

Submission Details

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
220d slower than avg
Panel avg: 114d · This submission: 334d
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

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