K250916
- 510(k) number
- K250916
- Device name
- WinForth (LM-E470KA)
- Applicant
- Shenzhen Leaflife Technology Co., Ltd. CN
- Product code
- PBX — Massager, Vacuum, Radio Frequency Induced Heat
- Decision date
- 2025-08-14
- Date received
- 2025-03-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K250916
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.