FDA 510(k)

JOULE 1064nm系统及附件

K号: K251077 · 2025-12-19

决定日期2025-12-19

产品代码GEX

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决定实质等同

器械摘要

JOULE 1064nm System and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Sciton, Inc. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K251077. 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 JOULE 1064nm System and Accessories?

JOULE 1064nm System and Accessories is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Sciton, Inc. The 510(k) number is K251077.

When did JOULE 1064nm System and Accessories receive FDA 510(k) clearance?

JOULE 1064nm System and Accessories received FDA 510(k) clearance on 2025-12-19, under 510(k) number K251077.

Who is the listed applicant for JOULE 1064nm System and Accessories?

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

What is the FDA product code for JOULE 1064nm System and Accessories?

The FDA product code for JOULE 1064nm System and Accessories is GEX. This falls under the Gastroenterology category.

列明Sciton, Inc为申报人的其他记录

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