510(k) K952028

COLD LIGHT SOURCE LOS XL-A 100 by Laser-Optik-Systeme GmbH & Co. KG — Product Code GCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1995
Date Received
May 1, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Endoscope, Xenon Arc
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type