Cleared Traditional

K003489 - NEXT GENERAL M20 SURGICAL LIGHT

Also marketed or referenced as:
NEXT GENERATION M16 MINOR SURGERY LIGHT NEXT GENERATION SPOTLIGHT NEXT GENERATION M8

K003489 is an FDA 510(k) clearance for NEXT GENERAL M20 SURGICAL LIGHT, manufactured by Medical Illumination International, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FSS cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K003489 · Medical Illumination International, Inc. · General & Plastic Surgery device
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Feb 2001
Decision
81d
Days
Class 2
Risk

K003489 is an FDA 510(k) clearance for the NEXT GENERAL M20 SURGICAL LIGHT. Classified as Light, Surgical, Floor Standing (product code FSS), Class II - Special Controls.

Submitted by Medical Illumination International, Inc. (San Fernando, US). The FDA issued a Cleared decision on February 2, 2001 after a review of 81 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 Illumination International, Inc. devices

FDA 510(k) Submission Details - K003489

510(k) Number K003489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2000
Decision Date February 02, 2001
Days to Decision 81 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 115d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FSS Device Classification - Class 2, Special Controls

Product Code FSS Light, Surgical, Floor Standing
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.