510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K201904Substantially Equivalent

Monet Curing Laser

Cao Group, Inc., West Jordan UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201904 is the FDA 510(k) clearance record for Monet Curing Laser, a class II device, cleared for CAO Group, Inc. on under FDA product code QNF (Laser Activator For Polymerization). FDA's definition for product code QNF reads: "Intended to polymerize dental restorative resins". FDA records list 33 510(k) clearances for CAO Group, Inc., from to . As of , FDA records show no recalls naming K201904.

Clearance record

Decision date
Received
(138 days to decision)
Product code
QNF Laser Activator For Polymerization
Regulation
21 CFR 872.6070
Device class
Class II
Review panel
Dental
Applicant
CAO Group, Inc. 4628 W. Skyhawk Dr., West Jordan UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QNF

Trailing 12 months

FDA records hold no clearances under product code QNF in the trailing twelve months.

FDA records show no clearances under product code QNF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QNF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260