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FDA 510(k)

D-STORM 810NM, D-STORM 980NM

K-Number: K093048 · 2010-03-23

ApplicantLight Instruments
Decision Date2010-03-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

D-STORM 810NM, D-STORM 980NM is the device name listed in this FDA 510(k) record. The listed applicant is Light Instruments. It received FDA 510(k) clearance on 2010-03-23 under 510(k) number K093048. 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 D-STORM 810NM, D-STORM 980NM?

D-STORM 810NM, D-STORM 980NM is a medical device that received FDA 510(k) clearance on 2010-03-23. The listed applicant is Light Instruments. The 510(k) number is K093048.

When did D-STORM 810NM, D-STORM 980NM receive FDA 510(k) clearance?

D-STORM 810NM, D-STORM 980NM received FDA 510(k) clearance on 2010-03-23, under 510(k) number K093048.

Who is the listed applicant for D-STORM 810NM, D-STORM 980NM?

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 D-STORM 810NM, D-STORM 980NM?

The FDA product code for D-STORM 810NM, D-STORM 980NM is GEX. This falls under the Gastroenterology category.

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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.

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Official Source

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