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FDA 510(k)

THE FRIENDLYLIGHT ND: YAG LASERS

K-Number: K033251 · 2004-03-02

ApplicantInnotech USA, Inc.
Decision Date2004-03-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THE FRIENDLYLIGHT ND: YAG LASERS is the device name listed in this FDA 510(k) record. The listed applicant is Innotech USA, Inc.. It received FDA 510(k) clearance on 2004-03-02 under 510(k) number K033251. 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 THE FRIENDLYLIGHT ND: YAG LASERS?

THE FRIENDLYLIGHT ND: YAG LASERS is a medical device that received FDA 510(k) clearance on 2004-03-02. The listed applicant is Innotech USA, Inc.. The 510(k) number is K033251.

When did THE FRIENDLYLIGHT ND: YAG LASERS receive FDA 510(k) clearance?

THE FRIENDLYLIGHT ND: YAG LASERS received FDA 510(k) clearance on 2004-03-02, under 510(k) number K033251.

Who is the listed applicant for THE FRIENDLYLIGHT ND: YAG LASERS?

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

What is the FDA product code for THE FRIENDLYLIGHT ND: YAG LASERS?

The FDA product code for THE FRIENDLYLIGHT ND: YAG LASERS is GEX. This falls under the Gastroenterology category.

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Other records listing Innotech USA, Inc. 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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