# MYC: Ophthalmoscope, Laser, Scanning

- Device class: 2; regulation: 21 CFR 886.1570; FDA's rule: 510(k) required
- FDA decisions: 23
- 510(k) review time 2021–2025: median 117 days (middle half 88–168)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2011: 2
- 2013: 1
- 2014: 2
- 2015: 2
- 2016: 1
- 2018: 2
- 2019: 1
- 2021: 2
- 2025: 2
- 2026: 1

## Most-cited predicates
- K142047: EIDON (2014), cited by 4
- K142897: P200DTx (2015), cited by 3
- K100644: Optos Limited Panoramic 200CAF (2010), cited by 2
- K102492: P200MAAF (2010), cited by 2
- K082016: GDX VCC with Ecc Software (2009), cited by 1
- K072259: Ophthalmoscope F-10 (2008), cited by 1
- K091039: Kowa, FM-600, Model LSS50 (2009), cited by 1
- K060424: Panoramic, Model 200MA (2006), cited by 1
- K211328: Eidon FA, Eidon, Eidon AF, Eidon Uwfl (2021), cited by 1
- K134039: Daytona Icg (P200TICG) (2014), cited by 1

Source page: https://510kreport.com/product-code/MYC
Data by year (CSV): https://510kreport.com/product-code/MYC.csv