K252187
- 510(k) number
- K252187
- Device name
- Aura Glide (FC40)
- Applicant
- Aura Medical, LLC NY · US
- Product code
- NFO — Stimulator, Transcutaneous Electrical, Aesthetic Pur
- Decision date
- 2025-12-23
- Date received
- 2025-07-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252187.pdf
Official FDA record: K252187
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.