Cleared Traditional

ACULUX, MODEL AX3001, AX3002 (K001223) - FDA 510(k) Clearance

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

K001223 · Aculux · General & Plastic Surgery device
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Jun 2000
Decision
67d
Days
Class 2
Risk

K001223 is an FDA 510(k) clearance for the ACULUX, MODEL AX3001, AX3002. Classified as Lamp, Operating-room (product code FQP), Class II - Special Controls.

Submitted by Aculux (Naples, US). The FDA issued a Cleared decision on June 23, 2000 after a review of 67 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 Aculux devices

Submission Details

510(k) Number K001223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2000
Decision Date June 23, 2000
Days to Decision 67 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
48d faster than avg
Panel avg: 115d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FQP Lamp, Operating-room
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.