Monet Curing Laser
FDA 510(k) clearance K201904 · decided 2020-11-24
Clearance details
- K-number
- K201904
- Device name
- Monet Curing Laser
- Applicant
- CAO Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-07-09
- Decision date
- 2020-11-24
- Days to decision
- 138 days
- Clearance type
- Traditional
- Product code
- QNF
- Device class
- 2
- Regulation number
- 872.6070
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- West Jordan, UT, US
- 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 |
|---|---|---|
| Fibercure (K232076) | Lumendo AG | 2023-11-02 |
Recalls involving this device
No recalls on record reference this clearance.