Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens +2 more— 510(k) K254269
Substantially EquivalentSt. shine Optical Co., Ltd.
FDA 510(k) clearance K254269 for Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens +2 more, Substantially Equivalent on 2026-03-19. Applicant: St. shine Optical Co., Ltd.. Device class: 2.
Summary
St. shine Optical's record lists three Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lenses: a standard version, a toric version and a multifocal version. They're filed under LPL, daily-wear soft contact lenses.
Class II, 21 CFR 886.5925. Ophthalmic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
St. shine Optical filed from New Taipei City, Taiwan. Review took 79 calendar days (December 30, 2025 to March 19, 2026).
Clearance details
- Device name as filed
- 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
- Applicant
- St. shine Optical Co., Ltd.
- Product code
- Product code LPL
- Device class
- Class 2
- Regulation
- 21 CFR 886.5925
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Taipei City, TW
Recent devices under product code LPL
view all- K260311 — Saview 60 UV (Omafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens +2 more
- K253875 — OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens +2 more
- K262941 — Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens
- K262495 — Miru 1day UpSide (midafilcon A)
- K260507 — Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus
More clearances from St. shine Optical Co., Ltd.
view all- K250364 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens +2 more
- K240477 — Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens +2 more
- 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
- K132146 — SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A)
- K123484 — SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS
Adverse events under product code LPL
product code LPL- Injury
- 988
- Other
- 4
- Total
- 992
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.