CAO Group, Inc.
FDA Regulatory Profile
CAO Group, Inc. appears in FDA public data with 4 recalls, 31 510(k) clearances, 6 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0290-2019, Class II) was initiated on November 16, 2018. Its most recent 510(k) clearance was granted on March 11, 2026.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 31
- Inspections
- 6
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
| D-0290-2019 | Class II | fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ ( | November 16, 2018 |
| D-0293-2019 | Class II | FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syringe | November 16, 2018 |
| D-0291-2019 | Class II | SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP, INC, 4628 | November 16, 2018 |
| D-0292-2019 | Class II | BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%. Packaged in: a) Intro | November 16, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
| K254197 | Picasso Pro Diode Laser (002-00460) | March 11, 2026 |
| K201904 | Monet Curing Laser | November 24, 2020 |
| K201475 | Ultimate Contour, Ultimate Contour Mini | October 28, 2020 |
| K181614 | Sterling Supreme Diode Laser | September 10, 2019 |
| K181602 | Pioneer Elite Diode Laser | September 10, 2019 |
| K181601 | Precise SHP Diode Laser | September 9, 2019 |
| K171052 | Ultimate Contour, Ultimate Contour Mini | October 20, 2017 |
| K171986 | Sterling Supreme Diode Laser | September 22, 2017 |
| K160413 | Sterling 5W Diode Laser | September 21, 2016 |
| K150585 | Ascent 3D | December 31, 2015 |
| K142223 | Pilot Pro Diode Laser | September 12, 2014 |
| K142225 | Pilot Elite Diode Laser | September 12, 2014 |
| K142226 | Pilot Ultra Diode Laser | September 12, 2014 |
| K131059 | PIONEER ELITE DIODE LASER | September 13, 2013 |
| K123443 | PRECISE SHP DIODE LASER | August 13, 2013 |
| K113472 | PRECISE SHP DIODE LASER | August 30, 2012 |
| K103160 | NUPRO MODEL 13016901 | January 6, 2011 |
| K100540 | ASCENT F-COAT MODEL: 006-00097 | September 23, 2010 |
| K100143 | PILOT DIODE LASER, MODEL 002-00139 | August 13, 2010 |
| K092616 | ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045 | October 21, 2009 |