Cleared Traditional

WinForth (LM-E470KA)

K250916 · Shenzhen Leaflife Technology Co., Ltd. · General & Plastic Surgery
Aug 2025
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K250916 is an FDA 510(k) clearance for the WinForth (LM-E470KA), a Massager, Vacuum, Radio Frequency Induced Heat (Class II — Special Controls, product code PBX), submitted by Shenzhen Leaflife Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 14, 2025, 140 days after receiving the submission on March 27, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number K250916 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code PBX — Massager, Vacuum, Radio Frequency Induced Heat
Device Class Class II — 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.