# HQB: Photocoagulator And Accessories

- Device class: 2; regulation: 21 CFR 886.4690; FDA's rule: 510(k) required
- FDA decisions: 30
- 510(k) review time 2021–2025: median 276 days (middle half 276–276)
- Recalls: 30 (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)
- 1988: 3
- 1992: 1
- 1993: 2
- 1995: 3
- 1997: 1
- 2011: 3
- 2012: 1
- 2013: 3
- 2019: 2
- 2022: 1

## Most-cited predicates
- K110228: Nidek Multicolor Laser Photocoagulator (2011), cited by 3
- K954307: Gamp & Assoc. Disposable Endoocular Laser Probe (1995), cited by 3
- K111493: Nidek Multicolor Scan Laser Photocoagulator MC-500 Vixi (2011), cited by 3
- K122997: 23GA Curved Illuminating Laser Probe (2013), cited by 2
- K110951: 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved Entry System, 27+ Infusion Cannula (2011), cited by 2
- K954308: Gamp & Assoc. Disposable Aspirating Endoocular Laser Probe (1995), cited by 1
- K191846: MAXReach Laser Probe (2019), cited by 1
- K113857: Synergetics Directional Endoocular Laser Probe (2012), cited by 1

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