Panels › Ophthalmic › Product code MYC · Class 2
Ophthalmoscope, Laser, Scanning
Regulation 886.1570
1510(k)s in 12 months (23 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in MYC
| Company | 510(k)s | Recalls |
|---|---|---|
| Centervue S.P.A. | 9 | 0 |
| Optos Plc. | 6 | 0 |
| Carl Zeiss Meditec, Inc. | 2 | 0 |
| Freedom Meditech, Inc. | 1 | 0 |
| I-Optics BV | 1 | 0 |
| Kowa Co. , Ltd. | 1 | 0 |
| Kowa Company, Ltd. Chofu Factory | 1 | 0 |
| Nidek Co., Ltd. | 1 | 0 |
| Ocusciences, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 2026 | K261255 | KOWA FM-600 Kowa Company, Ltd. Chofu Factory, JP | MYC |
| Apr 22, 2025 | K241931 | OcuMet Beacon (OCUB100) Ocusciences, Inc. | MYC |
| Mar 17, 2025 | K243504 | MAIA (AHMACME001) Centervue S.P.A., IT | MYC |
| Dec 21, 2021 | K213705 | DRSplus Centervue S.P.A., IT | MYC |
| Aug 19, 2021 | K211328 | EIDON FA, EIDON, EIDON AF, EIDON UWFL Centervue S.P.A., IT | MYC |
| Nov 15, 2019 | K192113 | DRSplus Centervue S.P.A., IT | MYC |
| Jul 16, 2018 | K180526 | EIDON FA Centervue S.P.A., IT | MYC |
| May 30, 2018 | K180293 | Retia 2 Centervue S.P.A., IT | MYC |
| Jun 8, 2016 | K153181 | MAIA Centervue S.P.A., IT | MYC |
| Jun 30, 2015 | K150320 | COMPASS Centervue S.P.A., IT | MYC |
| Jan 16, 2015 | K142897 | P200DTx Optos Plc., GB | MYC |
| Nov 12, 2014 | K142047 | EIDON Centervue S.P.A., IT | MYC |
| Apr 11, 2014 | K134039 | DAYTONA ICG (P200TICG) Optos Plc. | MYC |
| Jan 31, 2013 | K112880 | CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE Freedom Meditech, Inc. | MYC |
| Oct 28, 2011 | K111988 | EASYSCAN MODEL 1.2 I-Optics BV | MYC |
| Aug 19, 2011 | K111628 | P200T Optos Plc. | MYC |
| Sep 30, 2010 | K102492 | P200MAAF Optos Plc. | MYC |
| Jul 15, 2010 | K100644 | OPTOS LIMITED PANORAMIC 200CAF Optos Plc. | MYC |
| Nov 25, 2009 | K093521 | GDXPRO Carl Zeiss Meditec, Inc. | MYC |
| Aug 10, 2009 | K082016 | GDX VCC WITH ECC SOFTWARE Carl Zeiss Meditec, Inc. | MYC |
| Aug 7, 2009 | K091039 | KOWA, FM-600, MODEL LSS50 Kowa Co. , Ltd., JP | MYC |
| May 6, 2008 | K072259 | OPHTHALMOSCOPE F-10 Nidek Co., Ltd. | MYC |
| Mar 17, 2006 | K060424 | PANORAMIC, MODEL 200MA Optos Plc. | MYC |
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