# K030548: Saview 55 Multifocal (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear

- Pathway: 510(k) (Traditional)
- Applicant: St. shine Optical Co., Ltd.
- Decided: Apr 4, 2003 after 43 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 K953807 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020917: Saview 55F (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily Wear, St. shine Optical Co., Ltd. (2002)
- K021295: Saview Toric 55 (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily Wear, St. shine Optical Co., Ltd. (2002)
- K980818: Polyvue, Silver Chord and Unisoft (Methafilcon a) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lense), Stephen A. Dunn, Inc. (1998) Summary page 2.

## Indications for use
The Saview 55 Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity. The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.

Source page: https://510kreport.com/device/K030548
Methodology: https://510kreport.com/methodology