FDA.report

510(k) K935423

Device
COOL LIGHT 300
Applicant
ENDOSURGICAL DEVELOPMENT CORP.
510(k) number
K935423
Product code
GCT  
Decision
Substantially Equivalent (SESE)
Decision date
1994-01-26
Date received
1993-11-09
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
Statement
Third party reviewed
No

Related Records

Applicant Contact

Contact
ANTHONHY H FENDER
Address
1985 Rolling Vista Dr. Suite #52 Lomita CA US 90717 90717

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GCT  

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
K023468ENDOSCOPIC LIGHT SOURCE XL180/L3World of Medicine Lemke GmbH2003-01-14
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

Legacy Summary

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FDA Review

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