ProFlex CO2 Laser Fiber
K-Number: K203799 · 2021-09-20
ApplicantInnovaquartz, LLC
Decision Date2021-09-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
ProFlex CO2 Laser Fiber is a medical device manufactured by Innovaquartz, LLC. It received FDA 510(k) clearance on 2021-09-20 under approval number K203799. 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 ProFlex CO2 Laser Fiber?
ProFlex CO2 Laser Fiber is a medical device that received FDA 510(k) clearance on 2021-09-20. It is manufactured by Innovaquartz, LLC. The 510(k) number is K203799.
When was ProFlex CO2 Laser Fiber approved by the FDA?
ProFlex CO2 Laser Fiber received FDA 510(k) clearance on 2021-09-20, under approval number K203799.
What company makes ProFlex CO2 Laser Fiber?
ProFlex CO2 Laser Fiber is manufactured by Innovaquartz, LLC.
What is the FDA product code for ProFlex CO2 Laser Fiber?
The FDA product code for ProFlex CO2 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.