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FDA 510(k)

LITEDUO

K-Number: K073411 · 2008-05-13

ApplicantLight Instruments
Decision Date2008-05-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LITEDUO is the device name listed in this FDA 510(k) record. The listed applicant is Light Instruments. It received FDA 510(k) clearance on 2008-05-13 under 510(k) number K073411. 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 LITEDUO?

LITEDUO is a medical device that received FDA 510(k) clearance on 2008-05-13. The listed applicant is Light Instruments. The 510(k) number is K073411.

When did LITEDUO receive FDA 510(k) clearance?

LITEDUO received FDA 510(k) clearance on 2008-05-13, under 510(k) number K073411.

Who is the listed applicant for LITEDUO?

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

What is the FDA product code for LITEDUO?

The FDA product code for LITEDUO is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Light Instruments as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K093048D-STORM 810NM, D-STORM 980NM

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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