# HQN: Conformer, Ophthalmic

- Device class: 2; regulation: 21 CFR 886.3130; FDA's rule: 510(k) exempt
- FDA decisions: 7
- 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)
- 1977: 1
- 1992: 2
- 1995: 1
- 1997: 2
- 1998: 1

## Most-cited predicates
- K921221: Sterile/Single Use Symblepharon Ring (1992), cited by 1
- K945110: Kolberg Ophthalmic Conformer (1995), cited by 1

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