# Vizionfocus, Inc.

- Location (FDA's records): Miaoli County, TW
- FDA decisions: 5 (2018–2025): 5 510(k) clearances
- Product codes: LPL (5)
- 510(k) review time since 2016: median 111 days, against 128 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 11 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- CooperVision, Inc.: 4 (https://510kreport.com/company/coopervision)
- I-See Vision Technology, Inc.: 2 (https://510kreport.com/company/i-see-vision-technology)
- Bausch & Lomb, Inc.: 1 (https://510kreport.com/company/bausch-lomb)
- Sauflon Pharmaceuticals, Ltd.: 1 (https://510kreport.com/company/sauflon-pharmaceuticals)

## Its most-cited devices
- K182247: ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) (2018), cited by 2
- K242413: VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens (2024), cited by 1

## Recent decisions
- K251573: VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens (Sep 10, 2025)
- K243953: Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) (Apr 10, 2025)
- K242413: VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens (Dec 17, 2024)
- K192225: Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses (Dec 9, 2019)
- K182247: ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) (Oct 12, 2018)

Source page: https://510kreport.com/company/vizionfocus
