AuroLase® System
K-Number: K243701 · 2025-07-02
ApplicantNanospectra Biosciences, Inc.
Decision Date2025-07-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
AuroLase® System is a medical device manufactured by Nanospectra Biosciences, Inc.. It received FDA 510(k) clearance on 2025-07-02 under approval number K243701. 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 AuroLase® System?
AuroLase® System is a medical device that received FDA 510(k) clearance on 2025-07-02. It is manufactured by Nanospectra Biosciences, Inc.. The 510(k) number is K243701.
When was AuroLase® System approved by the FDA?
AuroLase® System received FDA 510(k) clearance on 2025-07-02, under approval number K243701.
What company makes AuroLase® System?
AuroLase® System is manufactured by Nanospectra Biosciences, Inc..
What is the FDA product code for AuroLase® System?
The FDA product code for AuroLase® System 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.