FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
Ponto 5 SuperPower
K Number: K213733
·
Decision Dec 16, 2021
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
50
Applicant Total
16
Review Days
20
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Basic Information
- Device Name
- Ponto 5 SuperPower
- K Number
- K213733
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 874.3302
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oticon Medical AB
- Date Received
- November 26, 2021
- Decision Date
- December 16, 2021
- Product Code
- LXB
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LXB | Hearing Aid, Bone Conduction | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LXB), ordered by most recent decision date.
Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
contact forte Alpha
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Ponto 5 Mini
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Oticon Medical AB
| K Number | Device Name | ||
|---|---|---|---|
| K240614 | Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS | Jul 10, 2024 | Substantially Equivalent |
| K211640 | Ponto 5 Mini | Aug 10, 2021 | Substantially Equivalent |
| K203807 | Ponto Bone Anchored Hearing System, MONO Surgery Kit | Mar 3, 2021 | Substantially Equivalent |
| K190540 | Ponto 4 | May 2, 2019 | Substantially Equivalent |
| K161671 | Ponto 3, Ponto 3 Power and Ponto 3 SuperPower | Sep 29, 2016 | Substantially Equivalent |
| K152820 | Ponto Bone Anchored Hearing System | Jan 22, 2016 | Substantially Equivalent |
| K152067 | Ponto bone anchored hearing system | Nov 23, 2015 | Substantially Equivalent |
| K142678 | Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm | Jan 21, 2015 | Substantially Equivalent |
| K141616 | STERILIZATION CASSETTE | Sep 23, 2014 | Substantially Equivalent |
| K132775 | PONTO PLUS AND PONTO PLUS POWER | Dec 9, 2013 | Substantially Equivalent |