Cleared Traditional

COLD LIGHT SOURCE LOS 150

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

About This 510(k) Submission

K951829 is an FDA 510(k) clearance for the COLD LIGHT SOURCE LOS 150, a Source, Carrier, Fiberoptic Light (Class I — General Controls, product code EQH), submitted by Laser Optik Systeme GmbH & Co. KG (Mainz, DE). The FDA issued a Cleared decision on July 10, 1995, 81 days after receiving the submission on April 20, 1995. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4350.

Submission Details

510(k) Number K951829 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EQH — Source, Carrier, Fiberoptic Light
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4350

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