# K244009: Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable)

- Pathway: 510(k) (Traditional)
- Applicant: Yung Sheng Optical Co., Ltd.
- Decided: Sep 25, 2025 after 273 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 K960926 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223585: Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear, Yung Sheng Optical Co., Ltd. (2023) Summary page 5.

## Indications for use
The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear and Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens are indicated for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The eye care professionals may prescribe the lens for single use daily disposable or reusable daily wear in a Frequent Replacement Program. DISPOSABLE WEAR: When prescribed for Disposable Wear, the Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens is to be discarded after each removal. FREQUENT/PLANNED REPLACEMENT WEAR: When prescribed for Frequent/Planned Replacement Wear, the Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear should be disinfected using a chemical or hydrogen peroxide disinfecting system each time it is removed and should be discarded per the eye care practitioner's guidance.

Source page: https://510kreport.com/device/K244009
Methodology: https://510kreport.com/methodology