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HLX — Photostimulator, Ac-Powered Class II

FDA Device Classification

Classification Details

Product Code
HLX
Device Class
Class II
Regulation Number
886.1630
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K003442electro-diagnostic imagingMODIFICATION TO EDI VERIS SYSTEMMay 4, 2001
K983983electro-diagnostic imagingEDI VERIS SYSTEMFebruary 3, 1999
K925741clarus medical systemsCLARUS ENDOSCOPIC HOOK KNIFEAugust 24, 1993
K914393retina testerRETINA TESTERMarch 2, 1992
K914163lkc technologiesSCOPTOPIC SENSITIVITY TEST-1[SST-1]October 25, 1991
K873990randwal instrument coIRAS EDS INTERFEROMETRIC STIMULATORFebruary 5, 1988
K853812biosan laboratoriesPHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)November 1, 1985
K833446vision health technologyDOWNING SPECTRAL ILLUMINATORMarch 12, 1984
K832762titmus opticalMILLER/NADLER GLARE TESTERSeptember 29, 1983
K831231cadwell laboratoriesLED GOGGLESMay 16, 1983
K830770cadwell laboratoriesCONTRAST SENSITIVITY EQUIPMENTApril 28, 1983
K822923life-tech intl5012 PARABOLIC STIMULATORDecember 28, 1982
K822922life-tech intl5011 GANZFELD STIMULATORDecember 28, 1982
K822915life-tech intl5031 BRIGHT FLASH STIMULATORDecember 28, 1982
K822919life-tech intl5010 VISUSTIMDecember 28, 1982
K812331nicolet biomedical instrumentsVTS-1000 VISUAL TESTING SYSTEMNovember 16, 1981
K810699visidynePANTOPS M-2 ELECTROPHYSIOLOGY SYSTEMJune 9, 1981
K790637potomac medical systemCOMPUTERIZED ELECTRO-OCULOGRAPHAugust 28, 1979