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FDA 510(k)

ALLEGRO OCULYZER

K-Number: K071183 · 2007-07-20

ApplicantWavelight AG
Decision Date2007-07-20
Product CodeMXK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ALLEGRO OCULYZER is the device name listed in this FDA 510(k) record. The listed applicant is Wavelight AG. It received FDA 510(k) clearance on 2007-07-20 under 510(k) number K071183. The device is classified under product code MXK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLEGRO OCULYZER?

ALLEGRO OCULYZER is a medical device that received FDA 510(k) clearance on 2007-07-20. The listed applicant is Wavelight AG. The 510(k) number is K071183.

When did ALLEGRO OCULYZER receive FDA 510(k) clearance?

ALLEGRO OCULYZER received FDA 510(k) clearance on 2007-07-20, under 510(k) number K071183.

Who is the listed applicant for ALLEGRO OCULYZER?

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

What is the FDA product code for ALLEGRO OCULYZER?

The FDA product code for ALLEGRO OCULYZER is MXK.

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Related Devices (Code: MXK)

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.

K251848Pentacam® Cornea OCTOculus Optikgeräte GmbHK252348Tomey Optical Biometer OA-2000 (OA-2000)Tomey CorporationK223700BOSS™Intelon Optics, Inc.K222933MYAHVisia Imaging S.R.L.K211868MYAHVisia Imaging S.R.L.K202989Myopia MasterOculus Optikgeräte GmbH

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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