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FDA 510(k)

VLS 5300 300W XENON LIGHT SOURCE

K-Number: K904681 · 1990-12-18

ApplicantVistek Corp.
Decision Date1990-12-18
Product CodeHBI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VLS 5300 300W XENON LIGHT SOURCE is the device name listed in this FDA 510(k) record. The listed applicant is Vistek Corp.. It received FDA 510(k) clearance on 1990-12-18 under 510(k) number K904681. The device is classified under product code HBI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VLS 5300 300W XENON LIGHT SOURCE?

VLS 5300 300W XENON LIGHT SOURCE is a medical device that received FDA 510(k) clearance on 1990-12-18. The listed applicant is Vistek Corp.. The 510(k) number is K904681.

When did VLS 5300 300W XENON LIGHT SOURCE receive FDA 510(k) clearance?

VLS 5300 300W XENON LIGHT SOURCE received FDA 510(k) clearance on 1990-12-18, under 510(k) number K904681.

Who is the listed applicant for VLS 5300 300W XENON LIGHT SOURCE?

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

What is the FDA product code for VLS 5300 300W XENON LIGHT SOURCE?

The FDA product code for VLS 5300 300W XENON LIGHT SOURCE is HBI.

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 Vistek Corp. 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: HBI)

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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