K251649
- 510(k) number
- K251649
- Device name
- Sunny Plus (Sunny)
- Applicant
- ShenB Co., Ltd. KR
- Product code
- NFO — Stimulator, Transcutaneous Electrical, Aesthetic Pur
- Decision date
- 2025-09-18
- Date received
- 2025-05-29
- 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: K251649.pdf
Official FDA record: K251649
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.