K251909
- 510(k) number
- K251909
- Device name
- NeurotriS (SX2500); NeurotriS (SX3800)
- Applicant
- A-1 Engineering CA · US
- Product code
- NFO — Stimulator, Transcutaneous Electrical, Aesthetic Pur
- Decision date
- 2025-09-03
- Date received
- 2025-06-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K251909.pdf
Official FDA record: K251909
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.