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FDA 510(k)

1125 XSB XENON FIBER-OPTIC LIGHT SOURCE

K-Number: K052979 · 2005-10-31

ApplicantIsolux, LLC
Decision Date2005-10-31
Product CodeHBI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

1125 XSB XENON FIBER-OPTIC LIGHT SOURCE is the device name listed in this FDA 510(k) record. The listed applicant is Isolux, LLC. It received FDA 510(k) clearance on 2005-10-31 under 510(k) number K052979. 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 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE?

1125 XSB XENON FIBER-OPTIC LIGHT SOURCE is a medical device that received FDA 510(k) clearance on 2005-10-31. The listed applicant is Isolux, LLC. The 510(k) number is K052979.

When did 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE receive FDA 510(k) clearance?

1125 XSB XENON FIBER-OPTIC LIGHT SOURCE received FDA 510(k) clearance on 2005-10-31, under 510(k) number K052979.

Who is the listed applicant for 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE?

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

What is the FDA product code for 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE?

The FDA product code for 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE is HBI.

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Other records listing Isolux, LLC 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.

K163185OptiLux LED IlluminatorK102266ISOLED AC-POWERED LED HEADLIGHT SYSTEM

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.

K223183Light-Guide CablesOlympus Winter & Ibe GmbHK163185OptiLux LED IlluminatorIsolux, LLCK111342LIGHT GUIDE CABLESchott North AmericaK021931ENDOSCOPIC FIBEROPTIC CABLEGulf Medical FiberopticsK991208ENDOSCOPIC FIBEROPTIC CABLEIsolux AmericaK983277LIGHTSOURCE OR ILLUMINATOR MODEL I-100Cuda Products Co.

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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