Cleared Traditional

25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY (K864166) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K864166 · Weck Surgical Systems · Neurology device
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Feb 1987
Decision
110d
Days
Class 3
Risk

K864166 is an FDA 510(k) clearance for the 25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY. Classified as Laser, Neurosurgical (product code LKW), Class III - Premarket Approval.

Submitted by Weck Surgical Systems (Hauppauge, US). The FDA issued a Cleared decision on February 10, 1987 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K864166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1986
Decision Date February 10, 1987
Days to Decision 110 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 148d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKW Laser, Neurosurgical
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.