MYC — Ophthalmoscope, Laser, Scanning Class II
FDA Device Classification
Classification Details
- Product Code
- MYC
- Device Class
- Class II
- Regulation Number
- 886.1570
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K241931 | ocusciences | OcuMet Beacon (OCUB100) | April 22, 2025 |
| K243504 | centervue | MAIA (AHMACME001) | March 17, 2025 |
| K213705 | centervue | DRSplus | December 21, 2021 |
| K211328 | centervue | EIDON FA, EIDON, EIDON AF, EIDON UWFL | August 19, 2021 |
| K192113 | centervue | DRSplus | November 15, 2019 |
| K180526 | centervue | EIDON FA | July 16, 2018 |
| K180293 | centervue | Retia 2 | May 30, 2018 |
| K153181 | centervue | MAIA | June 8, 2016 |
| K150320 | centervue | COMPASS | June 30, 2015 |
| K142897 | optos | P200DTx | January 16, 2015 |
| K142047 | centervue | EIDON | November 12, 2014 |
| K134039 | optos | DAYTONA ICG (P200TICG) | April 11, 2014 |
| K112880 | freedom meditech | CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE | January 31, 2013 |
| K111988 | i-optics | EASYSCAN MODEL 1.2 | October 28, 2011 |
| K111628 | optos | P200T | August 19, 2011 |
| K102492 | optos | P200MAAF | September 30, 2010 |
| K100644 | optos | OPTOS LIMITED PANORAMIC 200CAF | July 15, 2010 |
| K093521 | carl zeiss meditec | GDXPRO | November 25, 2009 |
| K082016 | carl zeiss meditec | GDX VCC WITH ECC SOFTWARE | August 10, 2009 |
| K091039 | kowa co. | KOWA, FM-600, MODEL LSS50 | August 7, 2009 |