CAO Group, Inc.: FDA clearances and approvals
CAO Group, Inc. has 31 FDA 510(k) clearances (first 2001, latest 2026), across 8 product codes in 2 review panels. Median 510(k) review time: 137 days. Since 2017 its median was 170 days, against 99 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 282 |
| 2013 | 2 | 214 |
| 2014 | 3 | 30 |
| 2015 | 1 | 297 |
| 2016 | 1 | 218 |
| 2017 | 2 | 137 |
| 2018 | 0 | — |
| 2019 | 3 | 448 |
| 2020 | 2 | 142 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 78 |
Review time against the same product codes
Since 2017, CAO Group, Inc.'s cleared 510(k)s took a median 170 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 99 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 16 | 16 |
| EBZ | Activator, Ultraviolet, For Polymerization | 3 | 3 |
| KLE | Agent, Tooth Bonding, Resin | 3 | 3 |
| LBH | Varnish, Cavity | 3 | 3 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 2 | 2 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 2 | 2 |
| EEG | Heat Source For Bleaching Teeth | 1 | 1 |
| QNF | Laser Activator For Polymerization | 1 | 1 |
Review panels
- General and Plastic Surgery (18)
- Dental (13)
Most recent CAO Group, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254197 | Picasso Pro Diode Laser (002-00460) | GEX | 2026-03-11 | 78 |
| K201904 | Monet Curing Laser | QNF | 2020-11-24 | 138 |
| K201475 | Ultimate Contour, Ultimate Contour Mini | PBX | 2020-10-28 | 147 |
| K181614 | Sterling Supreme Diode Laser | GEX | 2019-09-10 | 448 |
| K181602 | Pioneer Elite Diode Laser | GEX | 2019-09-10 | 448 |
| K181601 | Precise SHP Diode Laser | GEX | 2019-09-09 | 447 |
| K171052 | Ultimate Contour, Ultimate Contour Mini | PBX | 2017-10-20 | 193 |
| K171986 | Sterling Supreme Diode Laser | GEX | 2017-09-22 | 81 |
| K160413 | Sterling 5W Diode Laser | GEX | 2016-09-21 | 218 |
| K150585 | Ascent 3D | EBZ | 2015-12-31 | 297 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named CAO Group, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
CAO Group, Inc. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06173648: Histopathological Evaluation of the Periodontal Ligament Subjected to Laser Ablation. (Completed, started 2023-08-01)
- NCT04206384: Low-Frequency, High-Intensity Ultrasound for Waist Circumference Reduction (Completed, started 2019-12-02)
Frequently asked questions
How many FDA 510(k) clearances does CAO Group, Inc. have?
CAO Group, Inc. has 31 FDA 510(k) clearances (first 2001, latest 2026), across 8 product codes in 2 review panels.
How long does FDA take to clear CAO Group, Inc.'s 510(k)s?
The median time from FDA receipt to decision across CAO Group, Inc.'s cleared 510(k)s is 137 days. Since 2017: 170 days, versus 99 days for all cleared 510(k)s in the same product codes.
What devices does CAO Group, Inc. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 16); EBZ (Activator, Ultraviolet, For Polymerization, 3); KLE (Agent, Tooth Bonding, Resin, 3).
Has CAO Group, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching CAO Group, Inc. Related entities may recall under other names.
Next steps
- See all 31 CAO Group, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, CAO Group, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.