510(k) K201904
- Device
- Monet Curing Laser
- Applicant
- CAO Group, Inc.
- 510(k) number
- K201904
- Product code
- QNF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-11-24
- Date received
- 2020-07-09
- 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
- Robert K. Larsen
- Address
- 4628 W. Skyhawk Dr. West Jordan UT US 84084 84084
FDA Registration Numbers#
- 3030090167
- 3030405669
- 1725006
Source Documents#
Other 510(k) Records For Product Code QNF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232076 | Fibercure | Lumendo AG | 2023-11-02 |