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FDA 510(k)

QUADROSTAR 980

K-Number: K060459 · 2006-03-20

ApplicantAsclepion Laser Technologies GmbH
Decision Date2006-03-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

QUADROSTAR 980 is the device name listed in this FDA 510(k) record. The listed applicant is Asclepion Laser Technologies GmbH. It received FDA 510(k) clearance on 2006-03-20 under 510(k) number K060459. 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 QUADROSTAR 980?

QUADROSTAR 980 is a medical device that received FDA 510(k) clearance on 2006-03-20. The listed applicant is Asclepion Laser Technologies GmbH. The 510(k) number is K060459.

When did QUADROSTAR 980 receive FDA 510(k) clearance?

QUADROSTAR 980 received FDA 510(k) clearance on 2006-03-20, under 510(k) number K060459.

Who is the listed applicant for QUADROSTAR 980?

The FDA 510(k) record lists Asclepion Laser Technologies GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUADROSTAR 980?

The FDA product code for QUADROSTAR 980 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.

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