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FDA 510(k)

xeo+ Family

K-Number: K233237 · 2023-12-15

ApplicantCutera, Inc.
Decision Date2023-12-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

xeo+ Family is the device name listed in this FDA 510(k) record. The listed applicant is Cutera, Inc.. It received FDA 510(k) clearance on 2023-12-15 under 510(k) number K233237. 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 xeo+ Family?

xeo+ Family is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Cutera, Inc.. The 510(k) number is K233237.

When did xeo+ Family receive FDA 510(k) clearance?

xeo+ Family received FDA 510(k) clearance on 2023-12-15, under 510(k) number K233237.

Who is the listed applicant for xeo+ Family?

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

What is the FDA product code for xeo+ Family?

The FDA product code for xeo+ Family 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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