# HLJ: Ophthalmoscope, Battery-Powered

- Device class: 2; regulation: 21 CFR 886.1570; FDA's rule: 510(k) exempt
- FDA decisions: 47
- 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)
- 1995: 4
- 1997: 2
- 2000: 1
- 2003: 1
- 2006: 3
- 2007: 1
- 2010: 1
- 2013: 3
- 2014: 1
- 2015: 2

## Most-cited predicates
- K123587: Heine Mini 3000 Led Ophthalmoscope (2013), cited by 3
- K760771: Sola Schultze-Crock Opthalmoscope (1976), cited by 3
- K925756: UNI II (1993), cited by 2
- K053425: Precision Optics Corporation Video Ophthalmoscope, Model 2500-Vos (2006), cited by 1
- K832437: Medic Lux Diagnostic Sets (1983), cited by 1
- K925757: Ophthalmoscope (1993), cited by 1
- K070270: Piccolight E50,Piccolight E56,Eurolight E10, Eurolight E30, and Eurolight E36 (2007), cited by 1

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