ATOVEN-Reusable Laser Fiber
K-Number: K152667 · 2016-06-09
ApplicantDiotech CO
Decision Date2016-06-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
ATOVEN-Reusable Laser Fiber is a medical device manufactured by Diotech CO. It received FDA 510(k) clearance on 2016-06-09 under approval number K152667. 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 ATOVEN-Reusable Laser Fiber?
ATOVEN-Reusable Laser Fiber is a medical device that received FDA 510(k) clearance on 2016-06-09. It is manufactured by Diotech CO. The 510(k) number is K152667.
When was ATOVEN-Reusable Laser Fiber approved by the FDA?
ATOVEN-Reusable Laser Fiber received FDA 510(k) clearance on 2016-06-09, under approval number K152667.
What company makes ATOVEN-Reusable Laser Fiber?
ATOVEN-Reusable Laser Fiber is manufactured by Diotech CO.
What is the FDA product code for ATOVEN-Reusable Laser Fiber?
The FDA product code for ATOVEN-Reusable Laser Fiber 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.