# HJO: Biomicroscope, Slit-Lamp, Ac-Powered

- Device class: 2; regulation: 21 CFR 886.1850; FDA's rule: 510(k) required
- FDA decisions: 109
- 510(k) review time 2021–2025: median 187 days (middle half 148–227)
- 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)
- 2013: 2
- 2014: 10
- 2015: 2
- 2016: 5
- 2017: 9
- 2018: 2
- 2020: 1
- 2022: 1
- 2024: 1
- 2026: 2

## Most-cited predicates
- K100202: Slit Lamp BO 900, BQ 900, BP900 (2010), cited by 7
- K082891: Lenstar, Model LS900 (2009), cited by 5
- K033190: Vision-Tech YZ Slit Lamp, Model 66 (2003), cited by 4
- K133476: Slit Lamps with SL Cam 5.0 Digital Imaging Solution (2014), cited by 3
- K131589: Keeler Slit Lamp H-Series (2013), cited by 3
- K982057: BC 900 Slit Lamp (1998), cited by 3
- K993357: Iolmaster (2000), cited by 3
- K063640: Kowa SL-15 (2006), cited by 3
- K992836: SL990, SL980, SL950 (1999), cited by 3
- K133667: Slit Lamp SL-D701 (2014), cited by 2

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