# St. shine Optical Co., Ltd.

- Location (FDA's records): New Taipei City, TW
- FDA decisions: 11 (2002–2026): 11 510(k) clearances
- Product codes: LPL (11)
- 510(k) review time since 2016: median 106 days, against 120 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 17 (8 its own); citations of its devices by later devices: 11 (8 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Optical Connection, Inc.: 4 (https://510kreport.com/company/optical-connection)
- Ciba Vision Corporation: 1 (https://510kreport.com/company/ciba-vision)
- Vistakon: 1 (https://510kreport.com/company/vistakon)
- Safilens, S.R.L.: 1 (https://510kreport.com/company/safilens)
- Vistakon, Johnson & Johnson Vision Products, Inc.: 1 (https://510kreport.com/company/vistakon-johnson-johnson-vision-products)
- Stephen A. Dunn, Inc.: 1 (https://510kreport.com/company/stephen-a-dunn)

## Firms that cite its devices most
- Visco Vision, Inc.: 1 (https://510kreport.com/company/visco-vision)
- Tangible Science, LLC: 1 (https://510kreport.com/company/tangible-science)
- Pegavision Corporation: 1 (https://510kreport.com/company/pegavision)

## Its most-cited devices
- K121201: Savie-Aqua 55UV (Methafilcon a) Tinnted Blue Soft (Hydrophilic) Contact Lens (2012), cited by 2
- K162317: Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens (2016), cited by 2
- K123484: Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal (Hefilcon a)Soft (Hydrophilic) Contact Lens (2013), cited by 1
- K132146: Saview-Aqua 58 UV (Etafilcon a) Visibility Tinted Soft (Hydrophilic) Contact Lens, Saview-Aqua 58 UV Toric (Etafilcon a) (2013), cited by 1
- 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 (2024), cited by 1
- K021295: Saview Toric 55 (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily Wear (2002), cited by 1

## Recent decisions
- 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 (Mar 19, 2026)
- 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 (Oct 7, 2025)
- 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 (Jul 1, 2024)
- K162317: Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens (Oct 21, 2016)
- K132146: Saview-Aqua 58 UV (Etafilcon a) Visibility Tinted Soft (Hydrophilic) Contact Lens, Saview-Aqua 58 UV Toric (Etafilcon a) (Aug 30, 2013)
- K123484: Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal (Hefilcon a)Soft (Hydrophilic) Contact Lens (Mar 29, 2013)
- K121201: Savie-Aqua 55UV (Methafilcon a) Tinnted Blue Soft (Hydrophilic) Contact Lens (Oct 26, 2012)
- K092852: Saview 58 UV; Toric & Multifocal (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear (Mar 11, 2010)

Source page: https://510kreport.com/company/st-shine-optical