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510(k) K003299

Device
OPD-SCAN, MODELS ARK-10000 AND ARK-9000
Applicant
NIDEK CO., LTD.
510(k) number
K003299
Product code
HLQ  
Decision
Se - With Limitations (SESU)
Decision date
2001-03-09
Date received
2000-10-20
Regulation
886.1350
Classification name
Keratoscope, Ac-powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CAROL PATTERSON
Address
21911 Erie Ln. Lake Forest CA US 92630 92630

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HLQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K973756EYE SYS VISTAEyesys Technologies, Inc.1997-11-13
K964290EYECHEKReichert Ophthalmic Instruments, Div. Leica, Inc.1997-01-09
K945382TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETERExpertech Assoc., Inc.1995-01-31
K944207TOPOGRAPHIC MODELING SYSTEM 2 TMS-2Computed Anatomy, Inc.1994-12-07
K944616KERATRON CORNEAL TOPOGRAPHERAlliance Medical Marketinig1994-11-22
K940647ORBSCAN(TM) KERATOMETEROrbtek, Inc.1994-07-06
K933556EH-270 CORNEAL TOPOGRAPHERVisioptic, Inc.1993-11-02
K923435CORNEAL TOPOGRAPHY SYSTEMPar Microsystems Corp.1993-02-16
K922253KERATOREF L60Luneau Ophtalmologie SA1992-06-19
K912740ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER)Visionary Systems, Inc.1991-12-30
K913022CCI VIDEOKERATOSCOPE/COMPARATORCci1991-10-09
K912130TBD KERATOSCOPEAlcon Laboratories1991-08-09
K895741CLAS PHOTOKERATOSCOPEKera-Metrics Corp.1990-07-11
K902012VKS-1 VIDEO KERATOSCOPEComputed Anatomy, Inc.1990-06-22
K901009MODEL 2000 INTRAOPERATIVE CORNEASCOPEKera Corp.1990-05-30

Legacy Summary#

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FDA Review#

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