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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Nanospectra Biosciences, Inc.. It received FDA 510(k) clearance on 2025-07-02 under 510(k) 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. The listed applicant is Nanospectra Biosciences, Inc.. The 510(k) number is K243701.

When did AuroLase® System receive FDA 510(k) clearance?

AuroLase® System received FDA 510(k) clearance on 2025-07-02, under 510(k) number K243701.

Who is the listed applicant for AuroLase® System?

The FDA 510(k) record lists Nanospectra Biosciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AuroLase® System?

The FDA product code for AuroLase® System is GEX. This falls under the Gastroenterology category.

Other records listing Nanospectra Biosciences, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GEX)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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