# K213216: Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Unicon Optical Co., Ltd.
- Decided: Jan 18, 2022 after 111 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 P810005 (1981). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160212: ACUVUE (senofilcon C) Soft Contact Lens, Johnson & Johnson Vision Care, Inc. (2016) Summary page 5.

## Most influential descendants
- K241707: OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ (2024), 0 descendants of its own

## Indications for use
The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and 1.00 diopter (D) or less of astigmatism. Eye Care Professionals may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, the lens is to be discarded after each removal. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical disinfection system only.

Source page: https://510kreport.com/device/K213216
Methodology: https://510kreport.com/methodology