FDA.reportPublic FDA data

510(k) K053475

Device
OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450
Applicant
REFRACTEC, INC.
510(k) number
K053475
Product code
HMR  
Decision
Substantially Equivalent (SESE)
Decision date
2006-03-03
Date received
2005-12-14
Regulation
886.4570
Classification name
Marker, Ocular
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GARY MOCNIK
Address
5 Jenner, Suite 150 Irvine CA US 92618 92618

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HMR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K925606OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERSChiron Vision Corp.1994-08-29
K872747LASER CENTERING DEVICEInnomed Corp.1987-09-04
K863663OPHTHALMIC SURGICAL OCULAR MARKERSMyocure, Inc.1986-10-20
K861535OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNUCooperVision, Inc.1986-05-14

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases