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FDA 510(k)

JOULE 1064nm System and Accessories

K-Number: K251077 · 2025-12-19

ApplicantSciton, Inc
Decision Date2025-12-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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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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