Cleared Traditional

K844440 - MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL (FDA 510(k) Clearance)

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

K844440 · Cooper Lasersonics, Inc. · Neurology device
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May 1985
Decision
174d
Days
Class 3
Risk

K844440 is an FDA 510(k) clearance for the MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL. Classified as Laser, Neurosurgical (product code LKW), Class III - Premarket Approval.

Submitted by Cooper Lasersonics, Inc. (Santa Clara, US). The FDA issued a Cleared decision on May 9, 1985 after a review of 174 days - an extended review cycle.

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.

View all Cooper Lasersonics, Inc. devices

Submission Details

510(k) Number K844440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1984
Decision Date May 09, 1985
Days to Decision 174 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 148d · This submission: 174d
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.