# HOY: Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

- Device class: 1; regulation: 21 CFR 886.4750; FDA's rule: 510(k) exempt
- FDA decisions: 55
- Recalls: 1 (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)
- 1988: 9
- 1989: 5
- 1990: 3
- 1991: 3
- 1992: 1
- 1993: 3
- 1994: 11
- 1997: 1
- 2005: 1
- 2014: 1

## Most-cited predicates
- K896171: Eye Patch (1989), cited by 1
- K050856: LCG (Liquide Crystal Glasses) System (2005), cited by 1
- K841599: Storz Universal Eye Shield (1984), cited by 1

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