# K253352: Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Pegavision Corporation
- Decided: May 21, 2026 after 233 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: 9 generations back to K962804 (1996). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232839: Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Yung Sheng Optical Co., Ltd. (2024) Summary page 5.

## Indications for use
Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia) in aphakic or non-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in powers ranging from +6.OOD to -12.OOD. Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia) in aphakic or non-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in powers ranging from +6.OOD to -12.OOD. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear. Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses and Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfecting and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.

Source page: https://510kreport.com/device/K253352
Methodology: https://510kreport.com/methodology