FDA 510(k)

LaserShot M, NaviLase

K-Number: K192008 · 2020-03-25

Decision Date2020-03-25

Product CodeMRX

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

LaserShot M, NaviLase is the device name listed in this FDA 510(k) record. The listed applicant is Vitrolife GmbH. It received FDA 510(k) clearance on 2020-03-25 under 510(k) number K192008. The device is classified under product code MRX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LaserShot M, NaviLase?

LaserShot M, NaviLase is a medical device that received FDA 510(k) clearance on 2020-03-25. The listed applicant is Vitrolife GmbH. The 510(k) number is K192008.

When did LaserShot M, NaviLase receive FDA 510(k) clearance?

LaserShot M, NaviLase received FDA 510(k) clearance on 2020-03-25, under 510(k) number K192008.

Who is the listed applicant for LaserShot M, NaviLase?

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

What is the FDA product code for LaserShot M, NaviLase?

The FDA product code for LaserShot M, NaviLase is MRX.

Related Devices (Code: MRX)

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.

K253333Assisted Reproduction Laser System (Model ILS-400M)Hua Yue Medical Technology Co., Ltd.K202241LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)Hamilton Thorne, Inc.

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.