Product code MYC
- Device name
- Ophthalmoscope, Laser, Scanning
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.1570
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241931 | OcuMet Beacon (OCUB100) | Ocusciences, Inc. | 2025-04-22 |
| K243504 | MAIA (AHMACME001) | Centervue S.P.A. | 2025-03-17 |
| K213705 | DRSplus | Centervue S.P.A. | 2021-12-21 |
| K211328 | EIDON FA, EIDON, EIDON AF, EIDON UWFL | Centervue S.P.A. | 2021-08-19 |
| K192113 | DRSplus | Centervue S.P.A. | 2019-11-15 |
| K180526 | EIDON FA | Centervue S.P.A. | 2018-07-16 |
| K180293 | Retia 2 | Centervue S.P.A. | 2018-05-30 |
| K153181 | MAIA | Centervue S.P.A. | 2016-06-08 |
| K150320 | COMPASS | Centervue S.P.A. | 2015-06-30 |
| K142897 | P200DTx | Optos Plc. | 2015-01-16 |
| K142047 | EIDON | Centervue S.P.A. | 2014-11-12 |
| K134039 | DAYTONA ICG (P200TICG) | Optos Plc. | 2014-04-11 |
| K112880 | CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE | Freedom Meditech, Inc. | 2013-01-31 |
| K111988 | EASYSCAN MODEL 1.2 | I-Optics BV | 2011-10-28 |
| K111628 | P200T | Optos Plc. | 2011-08-19 |
| K102492 | P200MAAF | Optos Plc. | 2010-09-30 |
| K100644 | OPTOS LIMITED PANORAMIC 200CAF | Optos Plc. | 2010-07-15 |
| K093521 | GDXPRO | Carl Zeiss Meditec, Inc. | 2009-11-25 |
| K082016 | GDX VCC WITH ECC SOFTWARE | Carl Zeiss Meditec, Inc. | 2009-08-10 |
| K091039 | KOWA, FM-600, MODEL LSS50 | Kowa Co. , Ltd. | 2009-08-07 |
| K072259 | OPHTHALMOSCOPE F-10 | Nidek Co., Ltd. | 2008-05-06 |
| K060424 | PANORAMIC, MODEL 200MA | Optos Plc. | 2006-03-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08053677040130 | MAIA | CENTERVUE SPA | 2026-04-29 |
| 08053677040123 | EIDON | CENTERVUE SPA | 2026-04-29 |
| G744OCUB100 | OcuMet Beacon | OcuSciences, Inc. | 2025-06-25 |
| 04059237000235 | SPECTRALIS | Heidelberg Engineering GmbH | 2025-03-24 |
| 04059237001034 | SPECTRALIS | Heidelberg Engineering GmbH | 2024-10-04 |
| 04059237001027 | SPECTRALIS | Heidelberg Engineering GmbH | 2024-10-04 |
| 04059237000792 | SPECTRALIS | Heidelberg Engineering GmbH | 2024-10-04 |
| 04059237000723 | SPECTRALIS | Heidelberg Engineering GmbH | 2024-10-04 |
| 04987669200636 | Image filing software NAVIS-EX | NIDEK CO.,LTD. | 2023-06-12 |
| 04987669101568 | Scanning Laser Ophthalmoscope | NIDEK CO.,LTD. | 2023-06-12 |
| 00849233012066 | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. | 2020-04-08 |
| 04059237000594 | SPECTRALIS | Heidelberg Engineering GmbH | 2019-04-23 |
| 04059237000211 | SPECTRALIS | Heidelberg Engineering GmbH | 2019-01-03 |
| 04059237000501 | SPECTRALIS | Heidelberg Engineering GmbH | 2019-01-03 |
| 04059237000341 | SPECTRALIS | Heidelberg Engineering GmbH | 2018-07-11 |
| 04059237000358 | SPECTRALIS | Heidelberg Engineering GmbH | 2018-07-11 |
| 04059237000396 | SPECTRALIS, HEP | Heidelberg Engineering GmbH | 2018-07-11 |
| 04059237000310 | SPECTRALIS | Heidelberg Engineering GmbH | 2017-06-30 |
| 04059237000242 | SPECTRALIS, HRT3, HEP | Heidelberg Engineering GmbH | 2016-12-16 |
| 04059237000105 | SPECTRALIS | Heidelberg Engineering GmbH | 2016-09-24 |
| 04059237000013 | SPECTRALIS | Heidelberg Engineering GmbH | 2016-09-24 |
| 04059237000020 | SPECTRALIS | Heidelberg Engineering GmbH | 2016-09-24 |
| 04059237000297 | SPECTRALIS | Heidelberg Engineering GmbH | 2016-09-24 |
| 04059237000280 | SPECTRALIS | Heidelberg Engineering GmbH | 2016-09-24 |
| 04059237000051 | SPECTRALIS | Heidelberg Engineering GmbH | 2016-09-24 |
| 04059237000150 | SPECTRALIS | Heidelberg Engineering GmbH | 2016-09-24 |
| 04059237000112 | SPECTRALIS | Heidelberg Engineering GmbH | 2016-09-24 |
| 04059237000099 | SPECTRALIS | Heidelberg Engineering GmbH | 2016-09-24 |
| 08719326032108 | EasyScan | EasyScan B.V. | 2016-09-17 |
| 04987669100523 | Image filing software | NIDEK CO.,LTD. | 2016-08-26 |