WinForth LM-E470KA
by Shenzhen Leaflife Technology Co., Ltd.
WinForth LM-E470KA is a radio-frequency skin contouring system generator (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 and listed in FDA GUDID since 22 Apr 2026 (UDI-DI 06974223650141), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06974223650141 | Date22 Apr 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK250916 | Date14 Aug 2025 | StatusActive |
Official records
- AccessGUDID record 06974223650141
- FDA 510(k) database K250916
Across registries
- FDA 510(k) K250916 decided 14 Aug 2025 Active
- FDA GUDID UDI-DI 06974223650141 listed 22 Apr 2026 Listed
Timeline
- Cleared FDA 510(k) K250916
- Listed FDA GUDID 06974223650141
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- WinForth
- Generic name
- Radio-frequency skin contouring system generator
- Model / reference
- LM-E470KA
- Primary DI / UDI-DI
- 06974223650141
- 510(k) Number
- FDA product code
- PBX
- GMDN term
- Radio-frequency skin contouring system generator
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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