FDA Product Code
FDA Product Code MYC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.1570
510(k) Clearances — 23 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261255 | KOWA FM-600 | Kowa Company, Ltd. Chofu Factory | 2026-09-11 | Traditional | PDF ↗ |
| K241931 | OcuMet Beacon (OCUB100) | Ocusciences, Inc. | 2025-04-22 | Traditional | PDF ↗ |
| K243504 | MAIA (AHMACME001) | Centervue S.P.A. | 2025-03-17 | Traditional | PDF ↗ |
| K213705 | DRSplus | Centervue S.P.A. | 2021-12-21 | Special | PDF ↗ |
| K211328 | EIDON FA, EIDON, EIDON AF, EIDON UWFL | Centervue S.P.A. | 2021-08-19 | Special | PDF ↗ |
| K192113 | DRSplus | Centervue S.P.A. | 2019-11-15 | Traditional | PDF ↗ |
| K180526 | EIDON FA | Centervue S.P.A. | 2018-07-16 | Traditional | PDF ↗ |
| K180293 | Retia 2 | Centervue S.P.A. | 2018-05-30 | Traditional | PDF ↗ |
| K153181 | MAIA | Centervue S.P.A. | 2016-06-08 | Traditional | PDF ↗ |
| K150320 | COMPASS | Centervue S.P.A. | 2015-06-30 | Traditional | PDF ↗ |
| K142897 | P200DTx | Optos Plc. | 2015-01-16 | Traditional | PDF ↗ |
| K142047 | EIDON | Centervue S.P.A. | 2014-11-12 | Traditional | PDF ↗ |
| K134039 | DAYTONA ICG (P200TICG) | Optos Plc. | 2014-04-11 | Traditional | PDF ↗ |
| K112880 | CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE | Freedom Meditech, Inc. | 2013-01-31 | Traditional | PDF ↗ |
| K111988 | EASYSCAN MODEL 1.2 | I-Optics BV | 2011-10-28 | Traditional | PDF ↗ |
| K111628 | P200T | Optos Plc. | 2011-08-19 | Special | PDF ↗ |
| K102492 | P200MAAF | Optos Plc. | 2010-09-30 | Special | PDF ↗ |
| K100644 | OPTOS LIMITED PANORAMIC 200CAF | Optos Plc. | 2010-07-15 | Traditional | PDF ↗ |
| K093521 | GDXPRO | Carl Zeiss Meditec, Inc. | 2009-11-25 | Traditional | PDF ↗ |
| K082016 | GDX VCC WITH ECC SOFTWARE | Carl Zeiss Meditec, Inc. | 2009-08-10 | Traditional | PDF ↗ |
| K091039 | KOWA, FM-600, MODEL LSS50 | Kowa Co. , Ltd. | 2009-08-07 | Traditional | PDF ↗ |
| K072259 | OPHTHALMOSCOPE F-10 | Nidek Co., Ltd. | 2008-05-06 | Abbreviated | PDF ↗ |
| K060424 | PANORAMIC, MODEL 200MA | Optos Plc. | 2006-03-17 | Special | PDF ↗ |
Product code MYC · Class II · Ophthalmic. Data: openFDA.