Cleared Traditional

K864610 - CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE (FDA 510(k) Clearance)

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

K864610 · Inframed, Inc. · Neurology device
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Jun 1987
Decision
210d
Days
Class 3
Risk

K864610 is an FDA 510(k) clearance for the CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE. Classified as Laser, Neurosurgical, Argon (product code LLF), Class III - Premarket Approval.

Submitted by Inframed, Inc. (Needham, US). The FDA issued a Cleared decision on June 18, 1987 after a review of 210 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 Inframed, Inc. devices

Submission Details

510(k) Number K864610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1986
Decision Date June 18, 1987
Days to Decision 210 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 148d · This submission: 210d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LLF Laser, Neurosurgical, Argon
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.