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FDA 510(k)

NLITE SYSTEM

K-Number: K014130 · 2002-01-08

ApplicantIcn Photonics , Ltd.
Decision Date2002-01-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NLITE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Icn Photonics , Ltd.. It received FDA 510(k) clearance on 2002-01-08 under 510(k) number K014130. 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 NLITE SYSTEM?

NLITE SYSTEM is a medical device that received FDA 510(k) clearance on 2002-01-08. The listed applicant is Icn Photonics , Ltd.. The 510(k) number is K014130.

When did NLITE SYSTEM receive FDA 510(k) clearance?

NLITE SYSTEM received FDA 510(k) clearance on 2002-01-08, under 510(k) number K014130.

Who is the listed applicant for NLITE SYSTEM?

The FDA 510(k) record lists Icn Photonics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NLITE SYSTEM?

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

Related Clinical Trials

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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Other records listing Icn Photonics , Ltd. 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.

K024189NLITE SYSTEM, MODEL#: A00-1025/A00-1033K020729NLITE SYSTEM,MODEL A00-1051K013461NLITE SYSTEM,MODEL A00-1025

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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