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FDA 510(k)

Picasso Pro Diode Laser (002-00460)

K-Number: K254197 · 2026-03-11

ApplicantCAO Group, Inc.
Decision Date2026-03-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Picasso Pro Diode Laser (002-00460) is the device name listed in this FDA 510(k) record. The listed applicant is CAO Group, Inc.. It received FDA 510(k) clearance on 2026-03-11 under 510(k) number K254197. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Picasso Pro Diode Laser (002-00460)?

Picasso Pro Diode Laser (002-00460) is a medical device that received FDA 510(k) clearance on 2026-03-11. The listed applicant is CAO Group, Inc.. The 510(k) number is K254197.

When did Picasso Pro Diode Laser (002-00460) receive FDA 510(k) clearance?

Picasso Pro Diode Laser (002-00460) received FDA 510(k) clearance on 2026-03-11, under 510(k) number K254197.

Who is the listed applicant for Picasso Pro Diode Laser (002-00460)?

The FDA 510(k) record lists CAO Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Picasso Pro Diode Laser (002-00460)?

The FDA product code for Picasso Pro Diode Laser (002-00460) is GEX. This falls under the Gastroenterology category.

Other records listing CAO Group, Inc. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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