DeviceClearance

Picasso Pro Diode Laser (002-00460)— 510(k) K254197

Substantially Equivalent

CAO Group, Inc.

FDA 510(k) clearance K254197 for Picasso Pro Diode Laser (002-00460), Substantially Equivalent on 2026-03-11. Applicant: CAO Group, Inc.. Device class: 2.

Summary

CAO Group's Picasso Pro Diode Laser (002-00460) is filed under GEX, powered laser surgical instruments. The record doesn't describe the laser beyond its name and that code name.

Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k).

CAO Group filed from West Jordan, Utah. The decision came 78 calendar days after receipt (December 23, 2025 to March 11, 2026).

Clearance details

Applicant
CAO Group, Inc.
Product code
Product code GEX
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
West Jordan, UT, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GEX

product code GEX
Death
33
Injury
3,045
Malfunction
12,903
Other
25
Total
16,006

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.