510(k) K230905
- Device
- OrthoPulse 2.0E (OPi2E-100)
- Applicant
- Biolux Technology GmbH
- 510(k) number
- K230905
- Product code
- PLH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-09
- Date received
- 2023-03-31
- Regulation
- 872.5470
- Classification name
- Orthodontic Led Accessory
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Daniela Penn
- Address
- Neubaugasse 31 Absdorf AT 3462 3462
FDA Registration Numbers#
- 3004355934
- 3017271131
- 3016114530
Source Documents#
Other 510(k) Records For Product Code PLH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K143120 | OrthoPulse | Biolux Research , Ltd. | 2015-07-24 |