K253932
- 510(k) number
- K253932
- Device name
- FACEGYM Pro Device (HD-109)
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd. CN
- Product code
- NFO — Stimulator, Transcutaneous Electrical, Aesthetic Pur
- Decision date
- 2026-07-23
- Date received
- 2025-12-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253932.pdf
Official FDA record: K253932
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.