LaserShot M, NaviLase
K-Number: K192008 · 2020-03-25
ApplicantVitrolife GmbH
Decision Date2020-03-25
Product CodeMRX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
LaserShot M, NaviLase is a medical device manufactured by Vitrolife GmbH. It received FDA 510(k) clearance on 2020-03-25 under approval 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. It is manufactured by Vitrolife GmbH. The 510(k) number is K192008.
When was LaserShot M, NaviLase approved by the FDA?
LaserShot M, NaviLase received FDA 510(k) clearance on 2020-03-25, under approval number K192008.
What company makes LaserShot M, NaviLase?
LaserShot M, NaviLase is manufactured by Vitrolife GmbH.
What is the FDA product code for LaserShot M, NaviLase?
The FDA product code for LaserShot M, NaviLase is MRX.
Related Devices (Code: MRX)
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.