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FDA 510(k)

VisuMax Femtosecond Laser

K-Number: K173371 · 2018-04-13

ApplicantCarl Zeiss Meditec, Inc.
Decision Date2018-04-13
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VisuMax Femtosecond Laser is a medical device manufactured by Carl Zeiss Meditec, Inc.. It received FDA 510(k) clearance on 2018-04-13 under approval number K173371. The device is classified under product code HNO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VisuMax Femtosecond Laser?

VisuMax Femtosecond Laser is a medical device that received FDA 510(k) clearance on 2018-04-13. It is manufactured by Carl Zeiss Meditec, Inc.. The 510(k) number is K173371.

When was VisuMax Femtosecond Laser approved by the FDA?

VisuMax Femtosecond Laser received FDA 510(k) clearance on 2018-04-13, under approval number K173371.

What company makes VisuMax Femtosecond Laser?

VisuMax Femtosecond Laser is manufactured by Carl Zeiss Meditec, Inc..

What is the FDA product code for VisuMax Femtosecond Laser?

The FDA product code for VisuMax Femtosecond Laser is HNO.

Related Clinical Trials

NCT07036835 Clinical Investigation of a Femtosecond Laser for Corneal Flap Creation ACTIVE_NOT_RECRUITING NCT01638390 Use of the VisuMax™ Femtosecond Laser COMPLETED

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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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