Cleared Traditional

K170499 - sensiLift

K170499 is an FDA 510(k) clearance for sensiLift, 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 118-day FDA review.

K170499 · El Global Trade, Ltd. · General & Plastic Surgery device
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Jun 2017
Decision
118d
Days
Class 2
Risk

K170499 is an FDA 510(k) clearance for the sensiLift. 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 June 15, 2017 after a review of 118 days - within the typical 510(k) review window.

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 El Global Trade, Ltd. devices

FDA 510(k) Submission Details - K170499

510(k) Number K170499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2017
Decision Date June 15, 2017
Days to Decision 118 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
3d slower than avg
Panel avg: 115d · This submission: 118d
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.