Cleared Traditional

K864386 - LUXTEC LOUPES FOR SURGICAL VISION

K864386 is an FDA 510(k) clearance for LUXTEC LOUPES FOR SURGICAL VISION, manufactured by Luxtec Corp.. The device is a Class 1 General & Plastic Surgery device with product code FSP cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K864386 · Luxtec Corp. · General & Plastic Surgery device
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Nov 1986
Decision
12d
Days
Class 1
Risk

K864386 is an FDA 510(k) clearance for the LUXTEC LOUPES FOR SURGICAL VISION. Classified as Loupe, Diagnostic/surgical (product code FSP), Class I - General Controls.

Submitted by Luxtec Corp. (Sturbridge, US). The FDA issued a Cleared decision on November 17, 1986 after a review of 12 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Luxtec Corp. devices

FDA 510(k) Submission Details - K864386

510(k) Number K864386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1986
Decision Date November 17, 1986
Days to Decision 12 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
103d faster than avg
Panel avg: 115d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

FSP Device Classification - Class 1, General Controls

Product Code FSP Loupe, Diagnostic/surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.