Cleared Traditional

K875042 - ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY (FDA 510(k) Clearance)

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

K875042 · Surgilase, Inc. · Neurology device
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Jun 1988
Decision
200d
Days
Class 3
Risk

K875042 is an FDA 510(k) clearance for the ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY. Classified as Laser, Neurosurgical (product code LKW), Class III - Premarket Approval.

Submitted by Surgilase, Inc. (Warwick, US). The FDA issued a Cleared decision on June 24, 1988 after a review of 200 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 Surgilase, Inc. devices

Submission Details

510(k) Number K875042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1987
Decision Date June 24, 1988
Days to Decision 200 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 148d · This submission: 200d
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.