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Nidek, Inc.

FDA 510(k) & PMA Approved Devices — 77 products

Total Devices77
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K050336 OPD-STATION SOFTWARENCF2005-08-24 View
510(k) K042785 MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300GEX2004-12-14 View
510(k) K031733 NON-CONTACT TONOMETER, MODEL NT-4000HKX2003-12-04 View
510(k) K032085 GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000GEX2003-10-03 View
510(k) K013694 NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)NFJ2002-11-19 View
510(k) K020876 ECHOSCAN, MODEL US-1800IYO2002-05-03 View
510(k) K014274 NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000HKI2002-04-17 View
510(k) K013760 DC-3300 LASER DIODE PHOTOCOAGULATORHQF2002-02-11 View
510(k) K013864 MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60GEX2002-02-08 View
510(k) K990119 EPI-STAR SURGICAL LASER SYSTERGEX2000-07-27 View
510(k) K990900 MICROKERATOME, MODEL MK-2000HNO1999-09-24 View
510(k) K991284 ANTERIOR EYE-SEGMENT ANALYSIS SYSTEMMXK1999-08-06 View
510(k) K980475 UNIPULSE CO2 SURGICAL LASER SYSTEMGEX1998-12-16 View
510(k) K982295 NIDEK LIGHTSCANGEX1998-08-06 View
510(k) K981447 DIO-LIGHT 60 LASER SYSTEMGEX1998-06-05 View
510(k) K980547 NIDEK PRIMA MODEL GYC-1500/2000GEX1998-05-13 View
510(k) K974732 NIDEK MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-7000GEX1998-03-18 View
510(k) K980201 DIO-LIGHT LASER SYSTEMGEX1998-03-16 View
510(k) K973828 PRIMA KTP LASER SYSTEMGEX1998-01-05 View
510(k) K973218 NIDEK HANDYHKI1997-11-04 View
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