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CAO Group, Inc.

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
31
Inspections
6
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0290-2019Class IIfas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (November 16, 2018
D-0293-2019Class IIFastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syringeNovember 16, 2018
D-0291-2019Class IISHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP, INC, 4628November 16, 2018
D-0292-2019Class IIBeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%. Packaged in: a) IntroNovember 16, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K254197Picasso Pro Diode Laser (002-00460)March 11, 2026
K201904Monet Curing LaserNovember 24, 2020
K201475Ultimate Contour, Ultimate Contour MiniOctober 28, 2020
K181614Sterling Supreme Diode LaserSeptember 10, 2019
K181602Pioneer Elite Diode LaserSeptember 10, 2019
K181601Precise SHP Diode LaserSeptember 9, 2019
K171052Ultimate Contour, Ultimate Contour MiniOctober 20, 2017
K171986Sterling Supreme Diode LaserSeptember 22, 2017
K160413Sterling 5W Diode LaserSeptember 21, 2016
K150585Ascent 3DDecember 31, 2015
K142226Pilot Ultra Diode LaserSeptember 12, 2014
K142223Pilot Pro Diode LaserSeptember 12, 2014
K142225Pilot Elite Diode LaserSeptember 12, 2014
K131059PIONEER ELITE DIODE LASERSeptember 13, 2013
K123443PRECISE SHP DIODE LASERAugust 13, 2013
K113472PRECISE SHP DIODE LASERAugust 30, 2012
K103160NUPRO MODEL 13016901January 6, 2011
K100540ASCENT F-COAT MODEL: 006-00097September 23, 2010
K100143PILOT DIODE LASER, MODEL 002-00139August 13, 2010
K092616ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045October 21, 2009