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FDA 510(k)

WAVELIGHT AURIGA

K-Number: K051399 · 2005-06-30

ApplicantWavelight Laser Technologie AG
Decision Date2005-06-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WAVELIGHT AURIGA is the device name listed in this FDA 510(k) record. The listed applicant is Wavelight Laser Technologie AG. It received FDA 510(k) clearance on 2005-06-30 under 510(k) number K051399. 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 WAVELIGHT AURIGA?

WAVELIGHT AURIGA is a medical device that received FDA 510(k) clearance on 2005-06-30. The listed applicant is Wavelight Laser Technologie AG. The 510(k) number is K051399.

When did WAVELIGHT AURIGA receive FDA 510(k) clearance?

WAVELIGHT AURIGA received FDA 510(k) clearance on 2005-06-30, under 510(k) number K051399.

Who is the listed applicant for WAVELIGHT AURIGA?

The FDA 510(k) record lists Wavelight Laser Technologie AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WAVELIGHT AURIGA?

The FDA product code for WAVELIGHT AURIGA is GEX. This falls under the Gastroenterology category.

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Other records listing Wavelight Laser Technologie AG 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.

K053604WAVELIGHT IDASK052806BURANEK050317BURANE XLK050218WAVELIGHT SINONK042474ARIONK040433SINON

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Related Devices (Code: GEX)

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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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