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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Focus Medical, LLC. It received FDA 510(k) clearance on 2016-06-29 under 510(k) 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. The listed applicant is Focus Medical, LLC. The 510(k) number is K152737.

When did Lite Touch receive FDA 510(k) clearance?

Lite Touch received FDA 510(k) clearance on 2016-06-29, under 510(k) number K152737.

Who is the listed applicant for Lite Touch?

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

What is the FDA product code for Lite Touch?

The FDA product code for Lite Touch is GEX. This falls under the Gastroenterology category.

Other records listing Focus Medical, LLC 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.

K152529NaturaLase CO2 Laser System

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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