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FDA 510(k)

ECO2 LASER SYSTEM

K-Number: K091115 · 2009-10-30

ApplicantLutronic Corporation
Decision Date2009-10-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ECO2 LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lutronic Corporation. It received FDA 510(k) clearance on 2009-10-30 under 510(k) number K091115. 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 ECO2 LASER SYSTEM?

ECO2 LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2009-10-30. The listed applicant is Lutronic Corporation. The 510(k) number is K091115.

When did ECO2 LASER SYSTEM receive FDA 510(k) clearance?

ECO2 LASER SYSTEM received FDA 510(k) clearance on 2009-10-30, under 510(k) number K091115.

Who is the listed applicant for ECO2 LASER SYSTEM?

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

What is the FDA product code for ECO2 LASER SYSTEM?

The FDA product code for ECO2 LASER SYSTEM 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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