510(k) K232076
- Device
- Fibercure
- Applicant
- Lumendo AG
- 510(k) number
- K232076
- Product code
- QNF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-11-02
- Date received
- 2023-07-13
- Regulation
- 872.6070
- Classification name
- Laser Activator For Polymerization
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Mark Bispinghoff
- Address
- Chemin Du Closel 5 Renens CH 1020 1020
FDA Registration Numbers#
- 3030090167
- 1725006
- 3030405669
Source Documents#
Other 510(k) Records For Product Code QNF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201904 | Monet Curing Laser | CAO Group, Inc. | 2020-11-24 |