Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens +2 more— 510(k) K240477
Substantially EquivalentSt. shine Optical Co., Ltd.
FDA 510(k) clearance K240477 for Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens +2 more, Substantially Equivalent on 2024-07-01. Applicant: St. shine Optical Co., Ltd.. Device class: 2.
Clearance details
- Device name as filed
- 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
- Applicant
- St. shine Optical Co., Ltd.
- Product code
- 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
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- K253352 — Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses +3 more
- K261299 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses +1 more
- K253885 — PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS +1 more
- K254269 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens +2 more
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
- 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
- K121201 — SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE 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.