# LYL: Accessories, Solution, Ultrasonic Cleaners For Lenses

- Device class: 2; regulation: 21 CFR 886.5928; FDA's rule: 510(k) required
- FDA decisions: 22
- 510(k) review time 2021–2025: median 156 days (middle half 107–206)
- Recalls: 13 (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: 1
- 1996: 2
- 1997: 1
- 1998: 1
- 1999: 2
- 2000: 1
- 2002: 3
- 2009: 1
- 2021: 1
- 2022: 1

## Most-cited predicates
- K022687: Aosept Clear Care Cleaning and Disinfecting Solution (2002), cited by 6
- K884414: Clensatron Automatic Contact Lens Cleaner (1988), cited by 4
- K974724: Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic Contact Lens Cleaner, Visonic Dome, Lensonic Contact (1998), cited by 3
- K902306: The Visonic Dome (TM) (1990), cited by 3
- K982115: Lenserver Automatic Contact Lens Cleaning Accessory (1999), cited by 2
- K083757: BPZ02 Multipurpose Solution (2009), cited by 2
- K962112: New Comfort Contact Lens Care Accessory (1996), cited by 2
- K921615: Lensonic (TM) Contact Lens Care Accessory (1992), cited by 2
- K020802: Renut Multiplus Mullti-Purpose Solution (2002), cited by 1
- K021699: Autolens Cleaning and Disinfecting Unit (2002), cited by 1

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