Data / Medical devices / Taiwan / ST. Shine Optical Co., Ltd.
ST. Shine Optical Co., Ltd.: FDA-registered device maker in Hsi Chih Dist, New Taipei City, Taiwan, 13 510(k) clearances
ST. Shine Optical Co., Ltd. is registered with the FDA (registration 9617499) in Hsi Chih Dist, New Taipei City, Taiwan. It lists 2 device types. The FDA files 13 510(k) clearances under its listings, the newest dated March 19, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9617499
- FEI number
- 3003714643
- Address
- 4,5 F/L No. 276-2 Sec. 1 Tatung RD., Hsi Chih Dist, New Taipei City, Taiwan, 221
- Owner or operator
- ST. SHINE OPTICAL CO., LTD. (9036007)
- Roles
- Manufacturer
- First device listed
- August 24, 2002
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact, (Disposable) | MVN | 2 | Manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 19, 2026 | 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 | Substantially Equivalent | St. shine Optical Co., Ltd. | accessdata.fda.gov |
| October 7, 2025 | 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 | Substantially Equivalent | St. shine Optical Co., Ltd. | accessdata.fda.gov |
| July 1, 2024 | 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 | Substantially Equivalent | St. shine Optical Co., Ltd. | accessdata.fda.gov |
| October 21, 2016 | 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 | Substantially Equivalent | St. shine Optical Co., Ltd. | accessdata.fda.gov |
| August 30, 2013 | K132146 | SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A) | LPL | Substantially Equivalent | St. shine Optical Co., Ltd. | accessdata.fda.gov |
| March 29, 2013 | K123484 | SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | St. shine Optical Co., Ltd. | accessdata.fda.gov |
| October 26, 2012 | K121201 | SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | St. shine Optical Co., Ltd. | accessdata.fda.gov |
| March 11, 2010 | K092852 | SAVIEW 58 UV; TORIC & MULTIFOCAL (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | LPL | Substantially Equivalent | St. shine Optical Co., Ltd. | accessdata.fda.gov |
| August 16, 2005 | K051095 | 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | LPL | Substantially Equivalent | Optical Connection, Inc. | accessdata.fda.gov |
| June 15, 2004 | K040900 | S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | LPL | Substantially Equivalent | Optical Connection, Inc. | accessdata.fda.gov |
| April 4, 2003 | K030548 | SAVIEW 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | LPL | Substantially Equivalent | St. shine Optical Co., Ltd. | accessdata.fda.gov |
| June 4, 2002 | K021295 | SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR | LPL | Substantially Equivalent | St. shine Optical Co., Ltd. | accessdata.fda.gov |
| May 6, 2002 | K020917 | SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR | LPL | Substantially Equivalent | St. shine Optical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 19, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.