Cleared Traditional

COLD LIGHT SOURCE LOS 150 (K951829) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K951829 · Laser Optik Systeme GmbH & Co. KG · Ear, Nose, Throat device
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Jul 1995
Decision
81d
Days
Class 1
Risk

K951829 is an FDA 510(k) clearance for the COLD LIGHT SOURCE LOS 150. Classified as Source, Carrier, Fiberoptic Light (product code EQH), Class I - General Controls.

Submitted by Laser Optik Systeme GmbH & Co. KG (Mainz, DE). The FDA issued a Cleared decision on July 10, 1995 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4350 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Laser Optik Systeme GmbH & Co. KG devices

Submission Details

510(k) Number K951829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1995
Decision Date July 10, 1995
Days to Decision 81 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 89d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EQH Source, Carrier, Fiberoptic Light
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.