510(k) · Cleared
ClearedMonet Curing Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CAO Group, Inc. · QNF Laser Activator For Polymerization
Cleared on Nov 24, 2020 as substantially equivalent to K160551 (Ultradent Products, Inc., 2016) after a 138-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Nov 24, 2020
- Review
- 138 days
- Class
- Class II
- Product code
- QNF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003383 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK003383 PalmlightUltradent Products, Inc. · 2001
- 3 generations backK083647 Valo, Model 5919Ultradent Products, Inc. · 2009
- 2 generations backK110582 Valo CordlessUltradent Products, Inc. · 2011
- 1 generation backK160551 VALO GrandUltradent Products, Inc. · 2016
- This deviceK201904 Monet Curing LaserCAO Group, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003383 | Palmlight | Ultradent Products, Inc. | 2001 | — |
| −3 | K083647 | Valo, Model 5919 | Ultradent Products, Inc. | 2009 | — |
| −2 | K110582 | Valo Cordless | Ultradent Products, Inc. | 2011 | — |
| −1 | K160551 | VALO Grand | Ultradent Products, Inc. | 2016 | — |
| 0 (this device) | K201904 | Monet Curing Laser | CAO Group, Inc. | 2020 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QNF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QNF device
- #1 K232076 Fibercurescore 7.5 · 5 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160551 | VALO GrandSummary page 4…fication: Class II Legally Marketed Predicate Devices for Substantial Equivalence: PRIMARY PREDICATE DEVICE- Valo Grand, manufactured by Ultradent Products, Inc. (K160551) Description of Submitted Device: The Monet Curing Laser is a device for delivering light energy to dental restorative material… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All QNF devicesQNF Laser Activator For Polymerization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QNF
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QNF
Too few QNF 510(k)s in any year since 2007 to give a median.
Recalls per year · QNF
No recall names QNF since 2007.
Adverse event reports per year · QNF
No MAUDE report names QNF since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Monet Curing Laser is a source of illumination for curing photo-activated dental restorative materials and adhesives.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201904 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201904: Monet Curing Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201904
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026