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FDA 510(k)

XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII

K-Number: K062895 · 2006-10-13

ApplicantDutch Ophthalmic Research Center International BV
Decision Date2006-10-13
Product CodeMPA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII is the device name listed in this FDA 510(k) record. The listed applicant is Dutch Ophthalmic Research Center International BV. It received FDA 510(k) clearance on 2006-10-13 under 510(k) number K062895. The device is classified under product code MPA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII?

XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII is a medical device that received FDA 510(k) clearance on 2006-10-13. The listed applicant is Dutch Ophthalmic Research Center International BV. The 510(k) number is K062895.

When did XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII receive FDA 510(k) clearance?

XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII received FDA 510(k) clearance on 2006-10-13, under 510(k) number K062895.

Who is the listed applicant for XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII?

The FDA 510(k) record lists Dutch Ophthalmic Research Center International BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII?

The FDA product code for XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII is MPA.

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Other records listing Dutch Ophthalmic Research Center International BV as applicant

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Related Devices (Code: MPA)

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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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