Cleared Traditional

K250916 - WinForth (LM-E470KA) (FDA 510(k) Clearance)

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

K250916 · Shenzhen Leaflife Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
140d
Days
Class 2
Risk

K250916 is an FDA 510(k) clearance for the WinForth (LM-E470KA). Classified as Massager, Vacuum, Radio Frequency Induced Heat (product code PBX), Class II - Special Controls.

Submitted by Shenzhen Leaflife Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 14, 2025 after a review of 140 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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 Shenzhen Leaflife Technology Co., Ltd. devices

Submission Details

510(k) Number K250916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2025
Decision Date August 14, 2025
Days to Decision 140 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 114d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PBX Massager, Vacuum, Radio Frequency Induced Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Generates Heat In Body Tissues For Minor Relief Of Minor Aches And Pain. Mechanical Massaging To Provide A Temporary Reduction In The Appearance Of Cellulite.
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 Consultant

Aestheticcert Compliance, LLC
Asher Zeng

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.

Regulatory Peers - PBX Massager, Vacuum, Radio Frequency Induced Heat

All 77
Devices cleared under the same product code (PBX) and FDA review panel - the closest regulatory comparables to K250916.
SPECCHIO
K260647 · El.En S.P.A. · Apr 2026
Apollo Quattro (APQ-10M)
K253261 · Weero Co., Ltd. · Mar 2026
NeoSculpt Plus
K252888 · S&M Medical Co., Ltd. · Mar 2026
OptiLUV Device
K250734 · Pollogen, Ltd. · Sep 2025
Zionic Pro Max (Radiofrequency)
K243716 · Termosalud S.L. · May 2025
HEBE (NP0000763)
K241733 · Novasonix Technology S.L. · Apr 2025