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FDA 510(k)

VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1

K-Number: K043503 · 2005-04-05

Decision Date2005-04-05
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1 is the device name listed in this FDA 510(k) record. The listed applicant is Visx, Incorporated. It received FDA 510(k) clearance on 2005-04-05 under 510(k) number K043503. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1?

VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1 is a medical device that received FDA 510(k) clearance on 2005-04-05. The listed applicant is Visx, Incorporated. The 510(k) number is K043503.

When did VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1 receive FDA 510(k) clearance?

VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1 received FDA 510(k) clearance on 2005-04-05, under 510(k) number K043503.

Who is the listed applicant for VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1?

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

What is the FDA product code for VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1?

The FDA product code for VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1 is HJO.

Related Clinical Trials

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.

Other records listing Visx, Incorporated 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.

Related Devices (Code: HJO)

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.

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.

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