Lite Touch
K-Number: K152737 · 2016-06-29
ApplicantFocus Medical, LLC
Decision Date2016-06-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Lite Touch is a medical device manufactured by Focus Medical, LLC. It received FDA 510(k) clearance on 2016-06-29 under approval number K152737. 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 Lite Touch?
Lite Touch is a medical device that received FDA 510(k) clearance on 2016-06-29. It is manufactured by Focus Medical, LLC. The 510(k) number is K152737.
When was Lite Touch approved by the FDA?
Lite Touch received FDA 510(k) clearance on 2016-06-29, under approval number K152737.
What company makes Lite Touch?
Lite Touch is manufactured by Focus Medical, LLC.
What is the FDA product code for Lite Touch?
The FDA product code for Lite Touch 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.