Cleared Traditional

K880172 - MODEL 4900 ND:YAG LASER FOR NEUROSURGER...

K880172 is an FDA 510(k) clearance for MODEL 4900 ND:YAG LASER FOR NEUROSURGER..., manufactured by Cooper Lasersonics, Inc.. The device is a Class 3 Neurology device with product code LKW cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K880172 · Cooper Lasersonics, Inc. · Neurology device
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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

FDA 510(k) Submission Details - K880172

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 148d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

LKW Device Classification - Class 3, Premarket Approval

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.