Cleared Traditional

K853580 - MEDILAS 2 (FDA 510(k) Clearance)

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

K853580 · Endo Lase, Inc. · Neurology device
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Feb 1986
Decision
171d
Days
Class 3
Risk

K853580 is an FDA 510(k) clearance for the MEDILAS 2. Classified as Laser, Neurosurgical (product code LKW), Class III - Premarket Approval.

Submitted by Endo Lase, Inc. (Washington, US). The FDA issued a Cleared decision on February 13, 1986 after a review of 171 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 Endo Lase, Inc. devices

Submission Details

510(k) Number K853580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1985
Decision Date February 13, 1986
Days to Decision 171 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 148d · This submission: 171d
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.