FDA 510(k) Applications for Medical Device Product Code "MYC"
(Ophthalmoscope,Laser,Scanning)

FDA 510(k) Number Applicant Device Name Decision Date
K093521 CARL ZEISS MEDITEC INC GDXPRO 11/25/2009
K082016 CARL ZEISS MEDITEC INC. GDX VCC WITH ECC SOFTWARE 08/10/2009
K150320 CENTERVUE SPA COMPASS 06/30/2015
K192113 CenterVue SpA DRSplus 11/15/2019
K213705 CenterVue SpA DRSplus 12/21/2021
K142047 CENTERVUE SPA EIDON 11/12/2014
K180526 CenterVue SpA EIDON FA 07/16/2018
K211328 CenterVue SpA EIDON FA, EIDON, EIDON AF, EIDON UWFL 08/19/2021
K153181 CENTERVUE SPA MAIA 06/08/2016
K180293 CenterVue SpA Retia 2 05/30/2018
K112880 FREEDOM MEDITECH, INC. CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE 01/31/2013
K111988 I-OPTICS BV EASYSCAN MODEL 1.2 10/28/2011
K091039 KOWA CO. LTD. KOWA, FM-600, MODEL LSS50 08/07/2009
K072259 NIDEK CO., LTD. OPHTHALMOSCOPE F-10 05/06/2008
K134039 OPTOS PLC DAYTONA ICG (P200TICG) 04/11/2014
K100644 OPTOS PLC OPTOS LIMITED PANORAMIC 200CAF 07/15/2010
K102492 OPTOS PLC P200MAAF 09/30/2010
K111628 OPTOS PLC P200T 08/19/2011
K060424 OPTOS PLC PANORAMIC, MODEL 200MA 03/17/2006
K142897 OPTOS PLC. P200DTx 01/16/2015


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