# K241707: OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™

- Pathway: 510(k) (Special)
- Applicant: Unicon Optical Co., Ltd.
- Decided: Jul 12, 2024 after 29 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: 7 generations back to P810005 (1981). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213216: Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens, Unicon Optical Co., Ltd. (2022) Summary page 6.
- K191929: UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens, Unicon Optical Co., Ltd. (2019) Summary page 6.
- K213119: Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens, Innova Vision, Inc. (2022) Summary page 6.

## Indications for use
OCuSOFT® AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by people who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity. OCuSOFT® AMENITY™ (linofilcon A) TORIC DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters. OCuSOFT® AMENITY™ (linofilcon A) MULTIFOCAL DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by people who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity. OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Source page: https://510kreport.com/device/K241707
Methodology: https://510kreport.com/methodology