Cleared Traditional

FLOOR STANDING, OPERATING AND EXAMINING LIGHT (K893813) - FDA 510(k) Clearance

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

K893813 · Astralite Corp. · General & Plastic Surgery device
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Jul 1989
Decision
52d
Days
Class 2
Risk

K893813 is an FDA 510(k) clearance for the FLOOR STANDING, OPERATING AND EXAMINING LIGHT. Classified as Light, Surgical, Floor Standing (product code FSS), Class II - Special Controls.

Submitted by Astralite Corp. (Diamond Springs, US). The FDA issued a Cleared decision on July 14, 1989 after a review of 52 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 Astralite Corp. devices

Submission Details

510(k) Number K893813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1989
Decision Date July 14, 1989
Days to Decision 52 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
63d faster than avg
Panel avg: 115d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.