Cleared Traditional

LASERMATIC SURGILASER MODEL 5050 (K870587) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K870587 · Lasermatic OY · Ear, Nose, Throat device
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Aug 1988
Decision
547d
Days
Class 2
Risk

K870587 is an FDA 510(k) clearance for the LASERMATIC SURGILASER MODEL 5050. Classified as Laser, Ent Microsurgical Carbon-dioxide (product code EWG), Class II - Special Controls.

Submitted by Lasermatic OY (Finland, FI). The FDA issued a Cleared decision on August 10, 1988 after a review of 547 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4500 - the FDA ear, nose and throat device framework. 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. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

View all Lasermatic OY devices

Submission Details

510(k) Number K870587 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 10, 1987
Decision Date August 10, 1988
Days to Decision 547 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
458d slower than avg
Panel avg: 89d · This submission: 547d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EWG Laser, Ent Microsurgical Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.