FDA 510(k)

Galilei G6 Lens Professional

K-Number: K182659 · 2019-07-25

ApplicantSis Ag, Surgical Instrument Systems

Decision Date2019-07-25

Product CodeMXK

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Galilei G6 Lens Professional is the device name listed in this FDA 510(k) record. The listed applicant is Sis Ag, Surgical Instrument Systems. It received FDA 510(k) clearance on 2019-07-25 under 510(k) number K182659. 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 Galilei G6 Lens Professional?

Galilei G6 Lens Professional is a medical device that received FDA 510(k) clearance on 2019-07-25. The listed applicant is Sis Ag, Surgical Instrument Systems. The 510(k) number is K182659.

When did Galilei G6 Lens Professional receive FDA 510(k) clearance?

Galilei G6 Lens Professional received FDA 510(k) clearance on 2019-07-25, under 510(k) number K182659.

Who is the listed applicant for Galilei G6 Lens Professional?

The FDA 510(k) record lists Sis Ag, Surgical Instrument Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Galilei G6 Lens Professional?

The FDA product code for Galilei G6 Lens Professional is MXK.

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 GmbH K252348Tomey Optical Biometer OA-2000 (OA-2000)Tomey Corporation K223700BOSS™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.