Medical Device Manufacturer · US , Littleton , CO

St. shine Optical Co., Ltd.

10 submissions · 10 cleared · Since 2002
10
Total
10
Cleared
0
Denied

St. shine Optical Co., Ltd. — FDA 510(k) Submissions

St. shine Optical Co., Ltd. has submitted 10 FDA 510(k) premarket notifications since 2002, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Lenses, Soft Contact, Daily Wear . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
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
K250364 · LPL Lenses, Soft Contact,... · Ophthalmic
Oct 2025 239d
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
K240477 · LPL Lenses, Soft Contact,... · Ophthalmic
Jul 2024 132d
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
K162317 · LPL Lenses, Soft Contact,... · Ophthalmic
Oct 2016 63d
SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A)
K132146 · LPL Lenses, Soft Contact,... · Ophthalmic
Aug 2013 50d
SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS
K123484 · LPL Lenses, Soft Contact,... · Ophthalmic
Mar 2013 136d
SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS
K121201 · LPL Lenses, Soft Contact,... · Ophthalmic
Oct 2012 190d
SAVIEW 58 UV; TORIC & MULTIFOCAL (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K092852 · LPL Lenses, Soft Contact,... · Ophthalmic
Mar 2010 176d
SAVIEW 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K030548 · LPL Lenses, Soft Contact,... · Ophthalmic
Apr 2003 43d
SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
K021295 · LPL Lenses, Soft Contact,... · Ophthalmic
Jun 2002 41d
SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
K020917 · LPL Lenses, Soft Contact,... · Ophthalmic
May 2002 46d
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