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 |
| K243504 | CENTERVUE SPA | MAIA (AHMACME001) | 03/17/2025 |
| 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 |
| K241931 | OcuSciences, Inc. | OcuMet Beacon (OCUB100) | 04/22/2025 |
| 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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