K232242
- 510(k) number
- K232242
- Device name
- BEAR 2 Body
- Applicant
- Foreo, Inc. NV · US
- Product code
- NFO — Stimulator, Transcutaneous Electrical, Aesthetic Pur
- Decision date
- 2024-05-13
- Date received
- 2023-07-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K232242
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.