Cleared Special

K062895 - XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K062895 · Dutch Ophthalmic Research Center International BV · Ophthalmic device
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Oct 2006
Decision
16d
Days
Class 2
Risk

K062895 is an FDA 510(k) clearance for the XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII. Classified as Endoilluminator (product code MPA), Class II - Special Controls.

Submitted by Dutch Ophthalmic Research Center International BV (Kingston, US). The FDA issued a Cleared decision on October 13, 2006 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 876.1500 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Dutch Ophthalmic Research Center International BV devices

Submission Details

510(k) Number K062895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2006
Decision Date October 13, 2006
Days to Decision 16 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 110d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MPA Endoilluminator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - MPA Endoilluminator

All 39
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