InnoVoyce Laser Fiber
K-Number: K220793 · 2022-05-25
ApplicantInnovoyce, LLC
Decision Date2022-05-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
InnoVoyce Laser Fiber is a medical device manufactured by Innovoyce, LLC. It received FDA 510(k) clearance on 2022-05-25 under approval number K220793. 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 InnoVoyce Laser Fiber?
InnoVoyce Laser Fiber is a medical device that received FDA 510(k) clearance on 2022-05-25. It is manufactured by Innovoyce, LLC. The 510(k) number is K220793.
When was InnoVoyce Laser Fiber approved by the FDA?
InnoVoyce Laser Fiber received FDA 510(k) clearance on 2022-05-25, under approval number K220793.
What company makes InnoVoyce Laser Fiber?
InnoVoyce Laser Fiber is manufactured by Innovoyce, LLC.
What is the FDA product code for InnoVoyce Laser Fiber?
The FDA product code for InnoVoyce 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.