K201904 is an FDA 510(k) clearance for the Monet Curing Laser. This device is classified as a Laser Activator For Polymerization (Class II - Special Controls, product code QNF).
Submitted by CAO Group, Inc. (West Jordan, US). The FDA issued a Cleared decision on November 24, 2020, 138 days after receiving the submission on July 9, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6070. Intended To Polymerize Dental Restorative Resins.
| 510(k) Number | K201904 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2020 |
| Decision Date | November 24, 2020 |
| Days to Decision | 138 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | QNF — Laser Activator For Polymerization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6070 |
| Definition | Intended To Polymerize Dental Restorative Resins |