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FDA 510(k)

LightForce LTS Model 1000, 1500, 2500, and 4000

K-Number: K173067 · 2018-02-22

ApplicantLitecure, LLC
Decision Date2018-02-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LightForce LTS Model 1000, 1500, 2500, and 4000 is a medical device manufactured by Litecure, LLC. It received FDA 510(k) clearance on 2018-02-22 under approval number K173067. 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 LightForce LTS Model 1000, 1500, 2500, and 4000?

LightForce LTS Model 1000, 1500, 2500, and 4000 is a medical device that received FDA 510(k) clearance on 2018-02-22. It is manufactured by Litecure, LLC. The 510(k) number is K173067.

When was LightForce LTS Model 1000, 1500, 2500, and 4000 approved by the FDA?

LightForce LTS Model 1000, 1500, 2500, and 4000 received FDA 510(k) clearance on 2018-02-22, under approval number K173067.

What company makes LightForce LTS Model 1000, 1500, 2500, and 4000?

LightForce LTS Model 1000, 1500, 2500, and 4000 is manufactured by Litecure, LLC.

What is the FDA product code for LightForce LTS Model 1000, 1500, 2500, and 4000?

The FDA product code for LightForce LTS Model 1000, 1500, 2500, and 4000 is GEX. This falls under the Gastroenterology category.

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Official Source

View on FDA Database →

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

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