# HLZ: Electrode, Corneal

- Device class: 2; regulation: 21 CFR 886.1220; FDA's rule: 510(k) required
- FDA decisions: 11
- 510(k) review time 2021–2025: median 129 days (middle half 129–129)
- 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)
- 1976: 1
- 1978: 1
- 1982: 2
- 1983: 1
- 1985: 1
- 1992: 1
- 1994: 1
- 1997: 1
- 2023: 1
- 2026: 1

## Most-cited predicates
- K813399: Erg-Jet Electrode (1982), cited by 2
- K844409: DTL Electrode (1985), cited by 1
- K820254: Gold Foil Erg Electrodes (1982), cited by 1
- K232273: RM Electrode (RMH 23-01) (2023), cited by 1
- K760199: Electroretinograph (1976), cited by 1

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