510(k) clearance
Ponto 5 Mini; Ponto 5 Superpower
- 510(k) number
- K261142
- Applicant
- Oticon Medical AB
- Decision date
- Aug 26, 2026
- Date received
- Apr 7, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- MAH
- Device type
- Hearing Aid, Bone Conduction, Implanted
- Device class
- Class II
- Regulation
- 21 CFR 874.3302
- Advisory committee
- Ear, Nose, Throat
- Statement or summary
- Summary
- Third party
- N
- Location
- Askim, SE