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FDA 510(k)

VISULAS TRION LASER SYSTEM WITH THE VITE OPTION

K-Number: K103056 · 2011-02-01

ApplicantCarl Zeiss Meditec, AG
Decision Date2011-02-01
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VISULAS TRION LASER SYSTEM WITH THE VITE OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2011-02-01 under 510(k) number K103056. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISULAS TRION LASER SYSTEM WITH THE VITE OPTION?

VISULAS TRION LASER SYSTEM WITH THE VITE OPTION is a medical device that received FDA 510(k) clearance on 2011-02-01. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K103056.

When did VISULAS TRION LASER SYSTEM WITH THE VITE OPTION receive FDA 510(k) clearance?

VISULAS TRION LASER SYSTEM WITH THE VITE OPTION received FDA 510(k) clearance on 2011-02-01, under 510(k) number K103056.

Who is the listed applicant for VISULAS TRION LASER SYSTEM WITH THE VITE OPTION?

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

What is the FDA product code for VISULAS TRION LASER SYSTEM WITH THE VITE OPTION?

The FDA product code for VISULAS TRION LASER SYSTEM WITH THE VITE OPTION is HQF.

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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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