Medical Device Manufacturer · US , Mchenry , IL

Nidek, Inc.

77 submissions · 77 cleared · Since 1983
77
Total
77
Cleared
0
Denied

Nidek, Inc. — FDA 510(k) Submissions

Nidek, Inc. has submitted 77 FDA 510(k) premarket notifications since 1983, of which 77 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Powered Laser Surgical Instrument, Laser, Ophthalmic, Refractometer, Ophthalmic, System, Imaging, Pulsed Echo, Ultrasonic, Instrument, Vitreous Aspiration And Cutting, Ac-powered . Use the specialty filter in the sidebar to narrow results.

77 devices
1–25 of 77
OPD-STATION SOFTWARE
K050336 · NCF Aberrometer, Ophthalmic · Ophthalmic
Aug 2005 195d
MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300
K042785 · GEX Powered Laser Surgical... · General & Plastic Surgery
Dec 2004 69d
NON-CONTACT TONOMETER, MODEL NT-4000
K031733 · HKX Tonometer, Ac-powered · Ophthalmic
Dec 2003 183d
GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000
K032085 · GEX Powered Laser Surgical... · General & Plastic Surgery
Oct 2003 88d
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
K013694 · NFJ System, Image Management,... · Ophthalmic
Nov 2002 377d
ECHOSCAN, MODEL US-1800
K020876 · IYO System, Imaging, Pulsed... · Radiology
May 2002 46d
NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000
K014274 · HKI Camera, Ophthalmic,... · Ophthalmic
Apr 2002 111d
DC-3300 LASER DIODE PHOTOCOAGULATOR
K013760 · HQF Laser, Ophthalmic · Ophthalmic
Feb 2002 90d
MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60
K013864 · GEX Powered Laser Surgical... · General & Plastic Surgery
Feb 2002 79d
EPI-STAR SURGICAL LASER SYSTER
K990119 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jul 2000 561d
MICROKERATOME, MODEL MK-2000
K990900 · HNO Keratome, Ac-powered · Ophthalmic
Sep 1999 190d
ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM
K991284 · MXK Device, Analysis,... · Ophthalmic
Aug 1999 113d
UNIPULSE CO2 SURGICAL LASER SYSTEM
K980475 · GEX Powered Laser Surgical... · General & Plastic Surgery
Dec 1998 313d
NIDEK LIGHTSCAN
K982295 · GEX Powered Laser Surgical... · General & Plastic Surgery
Aug 1998 36d
DIO-LIGHT 60 LASER SYSTEM
K981447 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jun 1998 44d
NIDEK PRIMA MODEL GYC-1500/2000
K980547 · GEX Powered Laser Surgical... · General & Plastic Surgery
May 1998 90d
NIDEK MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-7000
K974732 · GEX Powered Laser Surgical... · General & Plastic Surgery
Mar 1998 90d
DIO-LIGHT LASER SYSTEM
K980201 · GEX Powered Laser Surgical... · General & Plastic Surgery
Mar 1998 55d
PRIMA KTP LASER SYSTEM
K973828 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jan 1998 90d
NIDEK HANDY
K973218 · HKI Camera, Ophthalmic,... · Ophthalmic
Nov 1997 69d
NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)
K973533 · HKI Camera, Ophthalmic,... · Ophthalmic
Nov 1997 47d
NIDEK CYBERSCAN
K970017 · GEX Powered Laser Surgical... · General & Plastic Surgery
Mar 1997 75d
CYBERLASE CO2 LASER SYSTEM
K964353 · GEX Powered Laser Surgical... · General & Plastic Surgery
Feb 1997 119d
HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM
K960287 · HQC Unit, Phacofragmentation · Ophthalmic
Nov 1996 288d
NIDEK MODEL GYC-1500 AND GYC-2000
K951079 · HQF Laser, Ophthalmic · Ophthalmic
Sep 1995 189d

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