510(k) K201904
K201904 is an FDA 510(k) premarket notification submitted by CAO Group, Inc. for the device "Monet Curing Laser". The FDA issued a decision of Substantially Equivalent on November 24, 2020. The device falls under product code QNF (Laser Activator For Polymerization), a Class II device regulated under 21 CFR 872.6070. CAO Group, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 2020
- Date Received
- July 9, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser Activator For Polymerization
- Device Class
- Class II
- Regulation Number
- 872.6070
- Review Panel
- DE
- Submission Type
Intended to polymerize dental restorative resins