MYC — Ophthalmoscope, Laser, Scanning Class II
FDA product code MYC covers "Ophthalmoscope, Laser, Scanning", a Class II medical device regulated under 21 CFR 886.1570. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |