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FDA 510(k)

ADVANTAGE LASER SYSTEM

K-Number: K113502 · 2012-04-05

ApplicantLutronic Corporation
Decision Date2012-04-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ADVANTAGE 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 2012-04-05 under 510(k) number K113502. 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 ADVANTAGE LASER SYSTEM?

ADVANTAGE LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2012-04-05. The listed applicant is Lutronic Corporation. The 510(k) number is K113502.

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

ADVANTAGE LASER SYSTEM received FDA 510(k) clearance on 2012-04-05, under 510(k) number K113502.

Who is the listed applicant for ADVANTAGE 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 ADVANTAGE LASER SYSTEM?

The FDA product code for ADVANTAGE 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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