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FDA 510(k)

VISANTE OCT

K-Number: K051789 · 2005-09-30

ApplicantCarl Zeiss Meditec, Inc.
Decision Date2005-09-30
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VISANTE OCT is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, Inc.. It received FDA 510(k) clearance on 2005-09-30 under 510(k) number K051789. The device is classified under product code HLI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISANTE OCT?

VISANTE OCT is a medical device that received FDA 510(k) clearance on 2005-09-30. The listed applicant is Carl Zeiss Meditec, Inc.. The 510(k) number is K051789.

When did VISANTE OCT receive FDA 510(k) clearance?

VISANTE OCT received FDA 510(k) clearance on 2005-09-30, under 510(k) number K051789.

Who is the listed applicant for VISANTE OCT?

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

What is the FDA product code for VISANTE OCT?

The FDA product code for VISANTE OCT is HLI.

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Other records listing Carl Zeiss Meditec, Inc. as applicant

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.

K243878CLARUS (700)K233933CIRRUS™ HD-OCT Model 6000K230350VISULAS yagK231075Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)K222200CIRRUS HD-OCTK191194CLARUS

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Related Devices (Code: HLI)

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.

K153080RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc.K123316HEINE OMEGA 500Heine Optotechnik GmbH & Co. KGK121739IVUE WITH NORMATIVE DATABASEOptovue, Inc.K120057ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)Bioptigen, Inc.K120238RTVUE XR OCTOptovue, Inc.K111531RHA2020Annidis Health Systems Corp.

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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