FDA 510(k)

Picasso Pro 二极管激光器 (002-00460)

K号: K254197 · 2026-03-11

决定日期2026-03-11

产品代码GEX

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决定实质等同

器械摘要

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.

常见问题

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.

列明CAO Group, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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