OrthoPulse 2.0E (OPi2E-100)
FDA 510(k) clearance K230905 · decided 2023-06-09
Clearance details
- K-number
- K230905
- Device name
- OrthoPulse 2.0E (OPi2E-100)
- Applicant
- Biolux Technology GmbH
- Decision
- Substantially Equivalent
- Date received
- 2023-03-31
- Decision date
- 2023-06-09
- Days to decision
- 70 days
- Clearance type
- Special
- Product code
- PLH
- Device class
- 2
- Regulation number
- 872.5470
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Absdorf, AT
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OrthoPulse (K143120) | Biolux Research , Ltd. | 2015-07-24 |
Recalls involving this device
No recalls on record reference this clearance.