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 a medical device manufactured by CAO Group, Inc.. It received FDA 510(k) clearance on 2026-03-11 under approval 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. It is manufactured by CAO Group, Inc.. The 510(k) number is K254197.
When was Picasso Pro Diode Laser (002-00460) approved by the FDA?
Picasso Pro Diode Laser (002-00460) received FDA 510(k) clearance on 2026-03-11, under approval number K254197.
What company makes Picasso Pro Diode Laser (002-00460)?
Picasso Pro Diode Laser (002-00460) is manufactured by CAO Group, Inc..
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.
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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.