# K132146: Saview-Aqua 58 UV (Etafilcon a) Visibility Tinted Soft (Hydrophilic) Contact Lens, Saview-Aqua 58 UV Toric (Etafilcon a)

- Pathway: 510(k) (Traditional)
- Applicant: St. shine Optical Co., Ltd.
- Decided: Aug 30, 2013 after 50 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: 3 generations back to K051095 (2005). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092852: Saview 58 UV; Toric & Multifocal (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear, St. shine Optical Co., Ltd. (2010) Summary page 1.
- K121201: Savie-Aqua 55UV (Methafilcon a) Tinnted Blue Soft (Hydrophilic) Contact Lens, St. shine Optical Co., Ltd. (2012) Summary page 1.

## Most influential descendants
- K172692: Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens (2017), 1 descendant of its own
- K182734: Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac (2019), 0 descendants of its own

## Indications for use
The Saview-Aqua 58 UV (etafilcon 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 that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Saview-Aqua 58 UV Toric (etafilcon 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 that may exhibit refractive astigmatism up to 2.50 diapters that does not interfere with visual acuity. The Saview-Aqua 58 UV Multifocal (etafilcon 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 that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity and require add power of up to +3.25 diopters. The Saview-Aqua 58 UV, Saview-Aqua 58 UV Toric and Saview-Aqua 58 UV Multifocal lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are to 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/K132146
Methodology: https://510kreport.com/methodology