MYC
22 FDA 510(k) clearances · Product code
116 daysmedian time to decision
295 days90th percentile
22clearances measured
FDA profile
- Official device name
- Ophthalmoscope, Laser, Scanning
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Medical specialty
- Ophthalmic
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| OcuMet Beacon (OCUB100) (K241931) | Ocusciences, Inc. | 2025-04-22 |
| MAIA (AHMACME001) (K243504) | Centervue S.P.A. | 2025-03-17 |
| DRSplus (K213705) | Centervue S.P.A. | 2021-12-21 |
| EIDON FA, EIDON, EIDON AF, EIDON UWFL (K211328) | Centervue S.P.A. | 2021-08-19 |
| DRSplus (K192113) | Centervue S.P.A. | 2019-11-15 |
| EIDON FA (K180526) | Centervue S.P.A. | 2018-07-16 |
| Retia 2 (K180293) | Centervue S.P.A. | 2018-05-30 |
| MAIA (K153181) | Centervue S.P.A. | 2016-06-08 |
| COMPASS (K150320) | Centervue S.P.A. | 2015-06-30 |
| P200DTx (K142897) | Optos Plc. | 2015-01-16 |
| EIDON (K142047) | Centervue S.P.A. | 2014-11-12 |
| DAYTONA ICG (P200TICG) (K134039) | Optos Plc. | 2014-04-11 |
| CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE (K112880) | Freedom Meditech, Inc. | 2013-01-31 |
| EASYSCAN MODEL 1.2 (K111988) | I-Optics BV | 2011-10-28 |
| P200T (K111628) | Optos Plc. | 2011-08-19 |
| P200MAAF (K102492) | Optos Plc. | 2010-09-30 |
| OPTOS LIMITED PANORAMIC 200CAF (K100644) | Optos Plc. | 2010-07-15 |
| GDXPRO (K093521) | Carl Zeiss Meditec, Inc. | 2009-11-25 |
| GDX VCC WITH ECC SOFTWARE (K082016) | Carl Zeiss Meditec, Inc. | 2009-08-10 |
| KOWA, FM-600, MODEL LSS50 (K091039) | Kowa Co. , Ltd. | 2009-08-07 |
| OPHTHALMOSCOPE F-10 (K072259) | Nidek Co., Ltd. | 2008-05-06 |
| PANORAMIC, MODEL 200MA (K060424) | Optos Plc. | 2006-03-17 |
Track MYC automatically
Every clearance here is in the API, with alerts when new ones post.