# K141280: Ilens (Ocufilcon D) Daily Soft Contact Lens

- Pathway: 510(k) (Abbreviated)
- Applicant: Seinoh Optical Co., Ltd.
- Decided: Jul 18, 2014 after 63 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: 5 generations back to K942214 (1994). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091339: Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact Lens, CooperVision, Inc. (2010) Summary page 2.

## Most influential descendants
- K152657: SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens (2016), 0 descendants of its own

## Indications for use
The iLens® (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refmactive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-disease eyes in power from -20.001D to +20.001D. The lens may be worn by persons who exhibit refractive astigmatism of 2.0 diopters or less where the astigmatism does not interfere with visual acuity. Eye care practitioners may prescribe the lens for either single-use disposable wear or for frequent replacement wear. When prescribed for frequent replacement wear, the lens may be disinfected using a chemical or hydrogen peroxide disinfcting system. As prescribed for single use daily disposable wear, patients are instrucd to dispose of the lens at each removal. The iLens® Daily Wear Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Source page: https://510kreport.com/device/K141280
Methodology: https://510kreport.com/methodology