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510(k) K000327

Device
WAVESCAN WAVEFRONT SYSTEM MODEL HS 1
Applicant
VISX, INCORPORATED
510(k) number
K000327
Product code
HKO  
Decision
Se - With Limitations (SESU)
Decision date
2000-05-02
Date received
2000-02-02
Regulation
886.1760
Classification name
Refractometer, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAVID M PATINO
Address
3400 Central Expy. Santa Ana CA US 95051 95051

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HKO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K031831TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEMTopcon Medical Systems, Inc.2003-12-19
K951179DIGITAL RETINOSCOPIC PHOTOMETERKudi Kalu, Inc.1995-05-30
K945959VIDEO VISION ANALYZER (VIVA), VRB 100Tomey Corporation USA1995-03-01
K942242AUTO REF-KERATOMETER, RK-3Cannon U.S.A., Inc.1994-09-02
K940516AUTO REFF-30Canon, Inc.1994-07-12
K925304AUTOREF LENSMETER RL-10Canon USA, Inc.1994-02-17
K924741OPTEC 3000Stereo Optical Co., Inc.1993-04-06
K924790BURTON AUTO REFRACTOR - MODEL BAR-7R.H. Burton Co.1993-04-05
K924778BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8R.H. Burton Co.1993-04-05
K904828OPTEC 2300 AFVT, ARMED FORCES VISION TESTERStereo Optical Co., Inc.1991-01-18
K902500AR-1600G AUTO-REFRACTOMETERNidek, Inc.1990-07-27
K901583SHIN NIPPON AUTO REFRACTOMETER QR-007NSoderberg, Inc.1990-06-22
K901513NIDEK RT-1200S (MARCO TRS-1200)Nidek, Inc.1990-06-08
K890559NIDEK AR-1200Nidek, Inc.1989-02-27
K883200CANON AUTOREFRACTOMETER R-22Canon USA, Inc.1988-08-18

Legacy Summary#

summary

FDA Review#

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