# K251683: Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF)

- Pathway: 510(k) (Traditional)
- Applicant: Bruno Vision Care, LLC
- Decided: Dec 23, 2025 after 207 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K962804 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240918: Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism, Bruno Vision Care, LLC (2024) Summary page 5.

## Indications for use
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens for Presbyopia with Extended Depth of Focus (EDOF) is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in presbyopic phakic and aphakic persons with non-diseased eyes who exhibit 1.00D or less of astigmatism that does not interfere with visual acuity. The lens mitigates the effects of presbyopia by providing an Extended Depth of Focus (EDOF). Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens for Presbyopia with Extended Depth of Focus (EDOF) is to be prescribed for single-use disposable wear and are to be discarded after each removal.

Source page: https://510kreport.com/device/K251683
Methodology: https://510kreport.com/methodology