Cleared Traditional

K880172 - MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA. (FDA 510(k) Clearance)

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

K880172 · Cooper Lasersonics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1988
Decision
56d
Days
Class 3
Risk

K880172 is an FDA 510(k) clearance for the MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA.. 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 March 11, 1988 after a review of 56 days - a notably fast clearance 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 K880172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1988
Decision Date March 11, 1988
Days to Decision 56 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 148d · This submission: 56d
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.