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FDA 510(k)

LIGHTSTIC MODEL 180

K-Number: K962068 · 1996-11-08

ApplicantRare Earth Medical, Inc.
Decision Date1996-11-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIGHTSTIC MODEL 180 is the device name listed in this FDA 510(k) record. The listed applicant is Rare Earth Medical, Inc.. It received FDA 510(k) clearance on 1996-11-08 under 510(k) number K962068. 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 LIGHTSTIC MODEL 180?

LIGHTSTIC MODEL 180 is a medical device that received FDA 510(k) clearance on 1996-11-08. The listed applicant is Rare Earth Medical, Inc.. The 510(k) number is K962068.

When did LIGHTSTIC MODEL 180 receive FDA 510(k) clearance?

LIGHTSTIC MODEL 180 received FDA 510(k) clearance on 1996-11-08, under 510(k) number K962068.

Who is the listed applicant for LIGHTSTIC MODEL 180?

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

What is the FDA product code for LIGHTSTIC MODEL 180?

The FDA product code for LIGHTSTIC MODEL 180 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 Rare Earth Medical, 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.

K962965LIGHTSTIC MODEL 360

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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