Medilas H Laser Fibers
K-Number: K161771 · 2016-07-28
ApplicantDornier Medtech America, Inc.
Decision Date2016-07-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Medilas H Laser Fibers is a medical device manufactured by Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2016-07-28 under approval number K161771. 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 Medilas H Laser Fibers?
Medilas H Laser Fibers is a medical device that received FDA 510(k) clearance on 2016-07-28. It is manufactured by Dornier Medtech America, Inc.. The 510(k) number is K161771.
When was Medilas H Laser Fibers approved by the FDA?
Medilas H Laser Fibers received FDA 510(k) clearance on 2016-07-28, under approval number K161771.
What company makes Medilas H Laser Fibers?
Medilas H Laser Fibers is manufactured by Dornier Medtech America, Inc..
What is the FDA product code for Medilas H Laser Fibers?
The FDA product code for Medilas H Laser Fibers 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.