WinForth (LM-E470KA)
by Shenzhen Leaflife Technology Co., Ltd.
510(k) K250916
WinForth (LM-E470KA) is a medical device (FDA Class II; FDA product code PBX, Massager, Vacuum, Radio Frequency Induced Heat) made by Shenzhen Leaflife Technology Co., Ltd., cleared under FDA 510(k) K250916 on 14 Aug 2025, active as of 22 Oct 2026.
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK250916 | Date14 Aug 2025 | StatusActive |
Official records
- FDA 510(k) database K250916
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PBX
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K250916
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| WinForth LM-E470KA | LM-E470KA | 06974223650141 | — | On the market |
Similar devices
Other devices filed under FDA product code PBX (Massager, Vacuum, Radio Frequency Induced Heat).
- V30 system, V20 system, V10 system, V-VR Hand piece by VIORA LTD
- Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9) by INDIBA S.A.U.
- Palm NRG cellulite and muscle toning body device by HEAT IN A CLICK LLC
- NuEra Tight, NuEra Tight EMS by Bios S.R.L.
- V-FR Handpiece V-FR2002 by VIORA LTD
- ThermoTK by Zimmer Medizinsystems GmbH
- EndyMed Contour Handpiece by ENDYMED MEDICAL LTD
- RSHOCK by SWIMS AMERICA CORP
- InMode PLUS System by Inmode MD, Ltd.
- Venus Legacy CX by Venus Concept Inc.
Other devices from Shenzhen Leaflife Technology Co., Ltd.
See all devices from Shenzhen Leaflife Technology Co., Ltd. →