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510(k) K134039

Device
DAYTONA ICG (P200TICG)
Applicant
OPTOS PLC
510(k) number
K134039
Product code
MYC  
Decision
Substantially Equivalent (SESE)
Decision date
2014-04-11
Date received
2013-12-31
Regulation
886.1570
Classification name
Ophthalmoscope, Laser, Scanning
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RANDY PREBULA
Address
555 13th St., NW Washington DC US 20004 20004

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MYC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241931OcuMet Beacon (OCUB100)Ocusciences, Inc.2025-04-22
K243504MAIA (AHMACME001)Centervue S.P.A.2025-03-17
K213705DRSplusCentervue S.P.A.2021-12-21
K211328EIDON FA, EIDON, EIDON AF, EIDON UWFLCentervue S.P.A.2021-08-19
K192113DRSplusCentervue S.P.A.2019-11-15
K180526EIDON FACentervue S.P.A.2018-07-16
K180293Retia 2Centervue S.P.A.2018-05-30
K153181MAIACentervue S.P.A.2016-06-08
K150320COMPASSCentervue S.P.A.2015-06-30
K142897P200DTxOptos Plc.2015-01-16
K142047EIDONCentervue S.P.A.2014-11-12
K112880CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPEFreedom Meditech, Inc.2013-01-31
K111988EASYSCAN MODEL 1.2I-Optics BV2011-10-28
K111628P200TOptos Plc.2011-08-19
K102492P200MAAFOptos Plc.2010-09-30

Legacy Summary#

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FDA Review#

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