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FDA 510(k)

Elite iQ PRO (M122K1)

K-Number: K240396 · 2024-03-08

ApplicantCynosure, LLC
Decision Date2024-03-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Elite iQ PRO (M122K1) is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure, LLC. It received FDA 510(k) clearance on 2024-03-08 under 510(k) number K240396. 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 Elite iQ PRO (M122K1)?

Elite iQ PRO (M122K1) is a medical device that received FDA 510(k) clearance on 2024-03-08. The listed applicant is Cynosure, LLC. The 510(k) number is K240396.

When did Elite iQ PRO (M122K1) receive FDA 510(k) clearance?

Elite iQ PRO (M122K1) received FDA 510(k) clearance on 2024-03-08, under 510(k) number K240396.

Who is the listed applicant for Elite iQ PRO (M122K1)?

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

What is the FDA product code for Elite iQ PRO (M122K1)?

The FDA product code for Elite iQ PRO (M122K1) 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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