LISA Laser Surgical Fibers
K-Number: K220189 · 2022-04-29
ApplicantOmni-Guide Holdings, Inc.
Decision Date2022-04-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
LISA Laser Surgical Fibers is a medical device manufactured by Omni-Guide Holdings, Inc.. It received FDA 510(k) clearance on 2022-04-29 under approval number K220189. 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 LISA Laser Surgical Fibers?
LISA Laser Surgical Fibers is a medical device that received FDA 510(k) clearance on 2022-04-29. It is manufactured by Omni-Guide Holdings, Inc.. The 510(k) number is K220189.
When was LISA Laser Surgical Fibers approved by the FDA?
LISA Laser Surgical Fibers received FDA 510(k) clearance on 2022-04-29, under approval number K220189.
What company makes LISA Laser Surgical Fibers?
LISA Laser Surgical Fibers is manufactured by Omni-Guide Holdings, Inc..
What is the FDA product code for LISA Laser Surgical Fibers?
The FDA product code for LISA Laser Surgical 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.