510(k) K161671
- Device
- Ponto 3, Ponto 3 Power And Ponto 3 SuperPower
- Applicant
- OTICON MEDICAL AB
- 510(k) number
- K161671
- Product code
- LXB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-09-29
- Date received
- 2016-06-16
- Regulation
- 874.3300
- Classification name
- Hearing Aid, Bone Conduction
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Satu Hjartstam
- Address
- Datavagen 37b Askim SE SE-436 32 SE-436 32
FDA Registration Numbers#
- 3010097171
- 3014990990
- 9612468
- 3007743836
- 3027588012
- 9616024
- 3005150478
- 3014579188
- 3043654373
- 1045254
- 3007367732
- 3033905868
- 3007275459
- 3012593436
- 3013177549
- 3006405073
- 9710014
- 3034209804
- 9613646
- 8031010
- 3005900820
- 3009632672
- 3010376846
- 3003477135
- 3009307953
- 3020283264
- 3005216725
- 3007689689
- 3018094310
- 3009092818
- 3005820796
- 3003847101
Source Documents#
Other 510(k) Records For Product Code LXB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260452 | 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) | Zdeer Technology (Henan) Co., Ltd. | 2026-06-15 |
| K261256 | Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) | Shenzhen Magnet Technology Co., Ltd. | 2026-06-11 |
| K250215 | Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand | Cochlear | 2025-05-29 |
| K243041 | contact forte Alpha | Bhm-Tech Produktionsgesellschaft Mbh | 2025-04-25 |
| K213733 | Ponto 5 SuperPower | Oticon Medical AB | 2021-12-16 |
| K212136 | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App | Cochlear Americas | 2021-09-29 |
| K211640 | Ponto 5 Mini | Oticon Medical AB | 2021-08-10 |
| K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App | Cochlear Americas | 2021-02-23 |
| K190540 | Ponto 4 | Oticon Medical AB | 2019-05-02 |
| K172460 | ADHEAR System | Med-El Elektromedizinische Geraete GmbH | 2018-04-27 |
| K171088 | Cochlear Baha SoundArc | Cochlear Americas | 2017-06-07 |
| K153391 | Sophono Bone Conduction Systems (S) Configuration and (M) Configuration | Sophono, Inc. | 2016-06-16 |
| K161123 | Baha 5 Power Sound Processor | Cochlear Americas | 2016-05-20 |
| K153245 | Baha 5 Super Power Sound Processor | Cochlear Americas | 2016-03-02 |
| K150751 | Cordelle II Sound Processor | Cochlear Americas | 2015-07-22 |
Legacy Summary#
summary
FDA Review#
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