# HLI: Ophthalmoscope, Ac-Powered

- Device class: 2; regulation: 21 CFR 886.1570; FDA's rule: 510(k) exempt
- FDA decisions: 87
- Recalls: 5 (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)
- 2005: 2
- 2006: 3
- 2007: 1
- 2010: 2
- 2011: 3
- 2012: 2
- 2013: 2
- 2014: 4
- 2015: 2
- 2016: 1

## Most-cited predicates
- K121739: Ivue with Normative Database (2013), cited by 6
- K030433: Stratusoct with RNFL Normative Database (2003), cited by 5
- K033123: Stratusoct with RNFL & Macula Normative Database (2004), cited by 4
- K051789: Visante Oct (2005), cited by 4
- K871268: Rodenstock Scanning Laser Ophthalmoscope (1987), cited by 4
- K971671: Heidelberg Retina Angiograph FA/Icga (Hra/C) (1997), cited by 4
- K101505: Rtvue Model Rtvue 100 (2010), cited by 4
- K882517: Rodenstock Scanning Laser Ophthalmoscope (1989), cited by 3
- K983999: PANORAMIC200 Opthalmoscope (1999), cited by 3
- K153080: RTVue XR OCT Avanti with AngioVue Software (2016), cited by 3

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