Cleared Traditional

K951829 - COLD LIGHT SOURCE LOS 150

K951829 is an FDA 510(k) clearance for COLD LIGHT SOURCE LOS 150, manufactured by Laser Optik Systeme GmbH & Co. KG. The device is a Class 1 Ear, Nose, Throat device with product code EQH cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K951829 · Laser Optik Systeme GmbH & Co. KG · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K951829

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.

EQH Device Classification - Class 1, General Controls

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.

Regulatory Peers - EQH Source, Carrier, Fiberoptic Light

All 25
Devices cleared under the same product code (EQH) and FDA review panel - the closest regulatory comparables to K951829.
JED-LIGHT FIBEROPTIC LIGHT SOURCE
K954184 · Jedmed Instrument Co. · Nov 1995
ASPIRATING ENDO OCULAR PROBE
K930123 · Surgical Technologies, Inc. · Feb 1994
LX 150 LIGHT SOURCE
K922095 · Welch Allyn, Inc. · Jul 1992
ASPIRATING ENDO OCULAR PROBE
K914247 · Surgical Technologies, Inc. · Dec 1991
KAPS 90 DEGREE FIBEROPTIC ADAPTOR
K912885 · Jedmed Instrument Co. · Aug 1991
FIBEROPTIC LIGHT SOURCE, FOI-1A
K896384 · Jedmed Instrument Co. · Jan 1990