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FDA 510(k)

Lustre PRO Light System

K-Number: K143713 · 2016-01-19

ApplicantAmbicare Health, Ltd.
Decision Date2016-01-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Lustre PRO Light System is a medical device manufactured by Ambicare Health, Ltd.. It received FDA 510(k) clearance on 2016-01-19 under approval number K143713. 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 Lustre PRO Light System?

Lustre PRO Light System is a medical device that received FDA 510(k) clearance on 2016-01-19. It is manufactured by Ambicare Health, Ltd.. The 510(k) number is K143713.

When was Lustre PRO Light System approved by the FDA?

Lustre PRO Light System received FDA 510(k) clearance on 2016-01-19, under approval number K143713.

What company makes Lustre PRO Light System?

Lustre PRO Light System is manufactured by Ambicare Health, Ltd..

What is the FDA product code for Lustre PRO Light System?

The FDA product code for Lustre PRO Light System is GEX. This falls under the Gastroenterology category.

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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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