FDA.reportPublic FDA data

510(k) K023468

Device
ENDOSCOPIC LIGHT SOURCE XL180/L3
Applicant
World of Medicine Lemke GmbH
510(k) number
K023468
Product code
GCT
Decision
Substantially Equivalent (SESE)
Decision date
2003-01-14
Date received
2002-10-16
Regulation
876.1500
Classification name
Light Source, Endoscope, Xenon Arc
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
SUSANNE RAAB
Address
91 Trowbridge St. Cambridge MA US 02138 02138

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GCT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K093125ALPHAXENON LIGHT 180 W AND 300 WGimmi GmbH2010-01-27
K082925XENON-100 SCB LIGHT SOURCE, MODEL 20132620KARL STORZ Endoscopy-America, Inc.2008-12-18
K070376CONMED LINVATEC 300W XENON LIGHT SOURCEConmed Linvatec2007-08-20
K040949VIADUCT MINISCOPE AND ACCESSORIESAcueity, Inc.2004-05-07
K022490KSEA MEDI PACKKARL STORZ Endoscopy-America, Inc.2003-09-29
K031994LINVATEC 300W XENON LIGHT SOURCELinvatec Corp.2003-08-21
K021717ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5World of Medicine Lemke GmbH2002-08-20
K020889ENDOSCOPIC LIGHT SOURCE XL202/L3World of Medicine Lemke GmbH2002-06-05
K013880DAYLITE XENON LIGHT SOURCESDesigns For Vision, Inc.2001-12-07
K992540XENON LIGHT SOURCE PES 1Laser Optik Systeme GmbH & Co. KG1999-09-14
K992050LUMENON XENON LIGHT SOURCEWalter Lorenz Surgical, Inc.1999-09-14
K983628XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011Richard Wolf Medical Instruments Corp.1998-12-11
K982962XENON LIGHT SOURCE, MODELS LS6180, LS6035Contec Medical Vision, Ltd.1998-09-23
K981804XENON LIGHT SOURCE MODEL LS6000Contec Medical Vision, Ltd.1998-07-24
K980281WELCH ALLYN XENON 300 LIGHT SOURCEWelch Allyn, Inc.1998-02-27