Cleared Traditional

COLD LIGHT SOURCE LOS XL-A 100

K952028 · Laser Optik Systeme GmbH & Co. KG · Gastroenterology & Urology

Jul 1995

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K952028 is an FDA 510(k) clearance for the COLD LIGHT SOURCE LOS XL-A 100, a Light Source, Endoscope, Xenon Arc (Class II — Special Controls, product code GCT), submitted by Laser Optik Systeme GmbH & Co. KG (Mainz, DE). The FDA issued a Cleared decision on July 27, 1995, 87 days after receiving the submission on May 1, 1995. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K952028 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 1995
Decision Date	July 27, 1995
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement