Cleared Traditional

K904609 - XENON LIGHT SOURCE (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K904609 · Medical Dynamics, Inc. · General & Plastic Surgery device
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Dec 1990
Decision
68d
Days
Class 2
Risk

K904609 is an FDA 510(k) clearance for the XENON LIGHT SOURCE. Classified as Illuminator, Fiberoptic, Surgical Field (product code HBI), Class II - Special Controls.

Submitted by Medical Dynamics, Inc. (Englewood, US). The FDA issued a Cleared decision on December 18, 1990 after a review of 68 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medical Dynamics, Inc. devices

Submission Details

510(k) Number K904609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1990
Decision Date December 18, 1990
Days to Decision 68 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 114d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HBI Illuminator, Fiberoptic, Surgical Field
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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 General & Plastic Surgery devices follow this clearance model.