DEN240076
- 510(k) number
- DEN240076
- Device name
- Modius Lean
- Applicant
- Neurovalens Limited GB
- Product code
- SFW — Cranial Electrotherapy Stimulator For Weight Managem
- Decision date
- 2025-10-17
- Date received
- 2024-12-18
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Gastroenterology, Urology
Official FDA record: DEN240076
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.