Cleared Traditional

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

K880172 · Cooper Lasersonics, Inc. · Neurology device

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.. This device is classified as a Laser, Neurosurgical (Class III - Premarket Approval, product code LKW).

Submitted by Cooper Lasersonics, Inc. (Santa Clara, US). The FDA issued a Cleared decision on March 11, 1988, 56 days after receiving the submission on January 15, 1988.

This device falls under the Neurology FDA review panel.

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	—