# K250364: Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: St. shine Optical Co., Ltd.
- Decided: Oct 7, 2025 after 239 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: 2 generations back to K042275 (2004). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240477: Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens, St. shine Optical Co., Ltd. (2024) Summary page 5.

## Most influential descendants
- K254269: Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens (2026), 0 descendants of its own

## Indications for use
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00D of astigmatism or less does not interfere with visual acuity. Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes. The toric lens is specified for up to 3.00 diopters of astigmatism. The highest cylinder power is -3.00D. Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non- diseased eyes who may have 0.75D of astigmatism or less does not interfere with visual acuity. The multi-focal lens is specified for up to +3.00 diopters of add power. The highest add power is +3.00D. Saview SH Optic 38 UV, Saview SH Optic 38 UV toric, and Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is daily disposable wear. Eye care practitioners may prescribe the lens for daily disposable wear. The lens may be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.

Source page: https://510kreport.com/device/K250364
Methodology: https://510kreport.com/methodology