Single Use CO2 Laser Fiber (HAF005001)
K-Number: K243588 · 2025-02-19
ApplicantQuanta System Spa
Decision Date2025-02-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Single Use CO2 Laser Fiber (HAF005001) is a medical device manufactured by Quanta System Spa. It received FDA 510(k) clearance on 2025-02-19 under approval number K243588. 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 Single Use CO2 Laser Fiber (HAF005001)?
Single Use CO2 Laser Fiber (HAF005001) is a medical device that received FDA 510(k) clearance on 2025-02-19. It is manufactured by Quanta System Spa. The 510(k) number is K243588.
When was Single Use CO2 Laser Fiber (HAF005001) approved by the FDA?
Single Use CO2 Laser Fiber (HAF005001) received FDA 510(k) clearance on 2025-02-19, under approval number K243588.
What company makes Single Use CO2 Laser Fiber (HAF005001)?
Single Use CO2 Laser Fiber (HAF005001) is manufactured by Quanta System Spa.
What is the FDA product code for Single Use CO2 Laser Fiber (HAF005001)?
The FDA product code for Single Use CO2 Laser Fiber (HAF005001) 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.