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HLJ — Ophthalmoscope, Battery-Powered Class II

FDA Device Classification

Classification Details

Product Code
HLJ
Device Class
Class II
Regulation Number
886.1570
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K142486heine optotechnik gmbh and co. kgHEINE BETA 200, HEINE BETA 200 S, HEINE K 180May 18, 2015
K142837heine optotechnik gmbh and co. kgHEINE SIGMA 250 & HEINE SIGMA 250 M2January 29, 2015
K131959heine optotechnik gmbh and co. kgHEINE MINI 3000(R) OPHTHALMOSCOPEMarch 7, 2014
K131961heine optotechnik gmbh and co. kgHEINE BETA 200(R) OPHTHALMOSCOPEDecember 4, 2013
K131719medical devices (pvt)OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITSOctober 30, 2013
K123587heine optotechnik gmbh and co. kgHEINE MINI 3000 LED OPHTHALMOSCOPEMarch 22, 2013
K093495american diagnosticOTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITSNovember 19, 2010
K070270kirchner and wilhelm gmbh + co.kgPICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36November 5, 2007
K052599suzhou 66 vision tech co66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25November 7, 2006
K061278ophthalmosOPTYSE OPHTHALMOSCOPEMay 16, 2006
K053425precision opticsPRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOSJanuary 9, 2006
K032087keeler instrumentsKEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004November 26, 2003
K002044magna fortis corporationMAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KITSeptember 12, 2000
K962767alexander mfgMS401097-17,MS722-K,MS720,MS721,MS722July 3, 1997
K970029keeler instrumentsKEELER SPECTRA INDIRECT OPHTHALMOSCOPEApril 2, 1997
K950914rudolf riester gmbh and co. kgRI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTJuly 24, 1995
K950797neitz instruments companyHALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134March 28, 1995
K950796neitz instruments companyHALOGEN DIAGNOSTIC SET BX A - 12345March 22, 1995
K945640rudolf riester gmbh and co. kgRI-SCOPE S OTOSCOPEJanuary 17, 1995
K944402lacrimedicsFOCOMETERNovember 22, 1994