# HLX: Photostimulator, Ac-Powered

- Device class: 2; regulation: 21 CFR 886.1630; FDA's rule: 510(k) required
- FDA decisions: 18
- 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)
- 1982: 4
- 1983: 3
- 1984: 1
- 1985: 1
- 1988: 1
- 1991: 1
- 1992: 1
- 1993: 1
- 1999: 1
- 2001: 1

## Most-cited predicates
- K983983: Edi Veris System (1999), cited by 2
- K003442: Modification to Edi Veris System (2001), cited by 1
- K831231: Led Goggles (1983), cited by 1

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