St. shine Optical Co., Ltd.: FDA clearances and approvals
St. shine Optical Co., Ltd. has 11 FDA 510(k) clearances (first 2002, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time: 79 days. Since 2017 its median was 132 days, against 113 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 190 |
| 2013 | 2 | 93 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 63 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 132 |
| 2025 | 1 | 239 |
| 2026 | 1 | 79 |
Review time against the same product codes
Since 2017, St. shine Optical Co., Ltd.'s cleared 510(k)s took a median 132 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 11 | 11 |
Review panels
- Ophthalmic (11)
Most recent St. shine Optical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| 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 | LPL | 2026-03-19 | 79 |
| 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 | LPL | 2025-10-07 | 239 |
| 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 | LPL | 2024-07-01 | 132 |
| 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 | LPL | 2016-10-21 | 63 |
| K132146 | SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A) | LPL | 2013-08-30 | 50 |
| K123484 | SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS | LPL | 2013-03-29 | 136 |
| K121201 | SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS | LPL | 2012-10-26 | 190 |
| K092852 | SAVIEW 58 UV; TORIC & MULTIFOCAL (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | LPL | 2010-03-11 | 176 |
| K030548 | SAVIEW 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | LPL | 2003-04-04 | 43 |
| K021295 | SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR | LPL | 2002-06-04 | 41 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named St. shine Optical Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does St. shine Optical Co., Ltd. have?
St. shine Optical Co., Ltd. has 11 FDA 510(k) clearances (first 2002, latest 2026), across 1 product code in 1 review panel.
How long does FDA take to clear St. shine Optical Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across St. shine Optical Co., Ltd.'s cleared 510(k)s is 79 days. Since 2017: 132 days, versus 113 days for all cleared 510(k)s in the same product codes.
What devices does St. shine Optical Co., Ltd. make?
Its most frequent FDA product codes are LPL (Lenses, Soft Contact, Daily Wear, 11).
Has St. shine Optical Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching St. shine Optical Co., Ltd. Related entities may recall under other names.
Next steps
- See all 11 St. shine Optical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LPL, St. shine Optical Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.