WinForth (LM-E470KA)
FDA 510(k) K250916 · Shenzhen Leaflife Technology Co., Ltd.
510(k) numberK250916
Submission
- Device name
- WinForth (LM-E470KA)
- Applicant
- Shenzhen Leaflife Technology Co., Ltd.
Shenzhen, CN - Received
- March 27, 2025
- Decision date
- August 14, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- PBX – Massager, Vacuum, Radio Frequency Induced Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
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.
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| K253261 | Apollo Quattro (APQ-10M)PBX · Traditional | Weero Co., Ltd. | 03/13/2026SE |
| K252888 | NeoSculpt PlusPBX · Traditional | S&M Medical Co., Ltd. | 03/09/2026SE |
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| K243716 | Zionic Pro Max (Radiofrequency)PBX · Traditional | Termosalud S.L. | 05/28/2025SE |
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| K242175 | XOD Diathermia Radiofrequency DevicePBX · Traditional | Xod, Inc. | 02/27/2025SE |
| K241107 | Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba…PBX · Traditional | Indiba S. A. U. | 01/24/2025SE |
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| K212697 | Leaf SmoothOHT · Traditional | 11/19/2021SE |
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Questions and answers
When was WinForth (LM-E470KA) cleared by the FDA?
WinForth (LM-E470KA) (K250916) received a 510(k) decision of Substantially Equivalent on August 14, 2025, 140 days after the submission was received.
What is the product code of K250916?
The FDA product code is PBX – Massager, Vacuum, Radio Frequency Induced Heat, a Class II (moderate risk) device regulated under 21 CFR 878.4400.