St. Shine Optical Co., Ltd.
St. Shine Optical Co., Ltd. has 0 FDA recalls, 1 inspection, 11 510(k) clearances and 1 compliance action on record.
- Latest inspection
- May 23, 2013 · OAI
- Latest 510(k)
- Mar 19, 2026
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 11 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 13, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 23, 2013 | Tai Bei Shi, Taiwan | Devices | Official Action Indicated (OAI) | 3003714643 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under St. Shine Optical Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003714643 | Tai Bei Shi, Taiwan | 1 | May 23, 2013 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K254269 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH… | Mar 19, 2026 |
| K250364 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH… | Oct 7, 2025 |
| K240477 | Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV… | Jul 1, 2024 |
| K162317 | Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV… | Oct 21, 2016 |
| K132146 | SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV… | Aug 30, 2013 |
| K123484 | SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC)… | 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 |
| K030548 | SAVIEW 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Apr 4, 2003 |
| K021295 | SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR | Jun 4, 2002 |
| K020917 | SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR | May 6, 2002 |
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