510(k) K143120
- Device
- OrthoPulse
- Applicant
- BIOLUX RESEARCH LTD.
- 510(k) number
- K143120
- Product code
- PLH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-07-24
- Date received
- 2014-10-30
- Regulation
- 872.5470
- Classification name
- Orthodontic Led Accessory
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kevin Strange
- Address
- 825 Powell St., Suite 220 Vancouver CA V6A 1H7 V6A 1H7
FDA Registration Numbers#
- 3004355934
- 3017271131
- 3016114530
Source Documents#
Other 510(k) Records For Product Code PLH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230905 | OrthoPulse 2.0E (OPi2E-100) | Biolux Technology GmbH | 2023-06-09 |
Legacy Summary#
summary
FDA Review#
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