Nidek, Inc. - FDA 510(k) Cleared Devices
77
Total
77
Cleared
0
Denied
22 devices
Cleared
Dec 14, 2004
MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300
General & Plastic Surgery
69d
Cleared
Oct 03, 2003
GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000
General & Plastic Surgery
88d
Cleared
Feb 08, 2002
MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60
General & Plastic Surgery
79d
Cleared
Jul 27, 2000
EPI-STAR SURGICAL LASER SYSTER
General & Plastic Surgery
561d
Cleared
Dec 16, 1998
UNIPULSE CO2 SURGICAL LASER SYSTEM
General & Plastic Surgery
313d
Cleared
Aug 06, 1998
NIDEK LIGHTSCAN
General & Plastic Surgery
36d
Cleared
Jun 05, 1998
DIO-LIGHT 60 LASER SYSTEM
General & Plastic Surgery
44d
Cleared
May 13, 1998
NIDEK PRIMA MODEL GYC-1500/2000
General & Plastic Surgery
90d
Cleared
Mar 18, 1998
NIDEK MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-7000
General & Plastic Surgery
90d
Cleared
Mar 16, 1998
DIO-LIGHT LASER SYSTEM
General & Plastic Surgery
55d
Cleared
Jan 05, 1998
PRIMA KTP LASER SYSTEM
General & Plastic Surgery
90d
Cleared
Mar 18, 1997
NIDEK CYBERSCAN
General & Plastic Surgery
75d
Cleared
Feb 28, 1997
CYBERLASE CO2 LASER SYSTEM
General & Plastic Surgery
119d
Cleared
Oct 21, 1991
NIDEK MODELS AC-2100 & 2200
General & Plastic Surgery
77d
Cleared
Feb 04, 1991
NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR
General & Plastic Surgery
175d
Cleared
Dec 07, 1990
NIDEK INC. MODEL AC-2000 DERM
General & Plastic Surgery
73d
Cleared
Sep 10, 1990
NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA
General & Plastic Surgery
195d
Cleared
Sep 10, 1990
NIDEK, INC. MODEL ADC-8000 DERM
General & Plastic Surgery
195d
Cleared
Jun 20, 1990
MODEL YC-1200/PHOTOCOAGULATOR OPHTHALMIC LASER
General & Plastic Surgery
83d
Cleared
Mar 27, 1990
NIDEK, INC. MODELS YC-1100 OPHTHALMIC LASERS
General & Plastic Surgery
74d
Cleared
Mar 22, 1990
NIDEK, INC. BIO-DC LASER DELIVERY SYSTEM
General & Plastic Surgery
69d
Cleared
Oct 04, 1989
NIDEK MODEL ADC-8000
General & Plastic Surgery
72d