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FDA 510(k)

LIGHTSTIC MODEL 360

K-Number: K962965 · 1997-01-09

ApplicantRare Earth Medical, Inc.
Decision Date1997-01-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIGHTSTIC MODEL 360 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 1997-01-09 under 510(k) number K962965. 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 360?

LIGHTSTIC MODEL 360 is a medical device that received FDA 510(k) clearance on 1997-01-09. The listed applicant is Rare Earth Medical, Inc.. The 510(k) number is K962965.

When did LIGHTSTIC MODEL 360 receive FDA 510(k) clearance?

LIGHTSTIC MODEL 360 received FDA 510(k) clearance on 1997-01-09, under 510(k) number K962965.

Who is the listed applicant for LIGHTSTIC MODEL 360?

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 360?

The FDA product code for LIGHTSTIC MODEL 360 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K962068LIGHTSTIC MODEL 180

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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