# HQF: Laser, Ophthalmic

- Device class: 2; regulation: 21 CFR 886.4390; FDA's rule: 510(k) required
- FDA decisions: 180
- 510(k) review time 2021–2025: median 131 days (middle half 86–245)
- Recalls: 23 (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)
- 2017: 3
- 2018: 1
- 2019: 4
- 2020: 4
- 2021: 1
- 2022: 7
- 2023: 5
- 2024: 3
- 2025: 3
- 2026: 2

## Most-cited predicates
- K020374: Oculight SL/SLX (2002), cited by 9
- K111108: Pascal Streamline 577 (with Accessories) (2011), cited by 7
- K050541: Omniguide Beampath CO2 Mark I Laser Beam Delivery (2005), cited by 5
- K960971: Oculight GL (1996), cited by 5
- K062624: Next Generation Laser (2007), cited by 4
- K931784: HGM Illuminating Imaging Endocular Probe (1994), cited by 4
- K092621: Pascal Streamline Photocoagulator (2009), cited by 4
- K013760: DC-3300 Laser Diode Photocoagulator (2002), cited by 4
- K131207: Femto LDV (TM) Z-Generation Femtosecond Surgical Laser (2013), cited by 3
- K100019: Pascal Streamline Photocoagulator (2010), cited by 3

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