Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal (Hefilcon A)Soft (Hydrophilic) Contact Lens
FDA 510(k) K123484 · St. shine Optical Co., Ltd.
510(k) numberK123484
Submission
- Device name
- Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal (Hefilcon A)Soft (Hydrophilic) Contact Lens
- Applicant
- St. shine Optical Co., Ltd.
Taipei Hsien, TW - Received
- November 13, 2012
- Decision date
- March 29, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LPL – Lenses, Soft Contact, Daily Wear
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5925
- Specialty
- Ophthalmic
Other 510(k)s with product code LPL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260507 | Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo…LPL · Traditional | INTEROJO, Inc. | 05/29/2026SE |
| K253352 | Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…LPL · Traditional | Pegavision Corporation | 05/21/2026SE |
| K261299 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…LPL · Special | Pegavision Corporation | 05/19/2026SE |
| K253885 | PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON…LPL · Traditional | Geo Medical Co., Ltd. | 04/29/2026SE |
| K254269 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens…LPL · Traditional | St. shine Optical Co., Ltd. | 03/19/2026SE |
| K252385 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…LPL · Traditional | Pegavision Corporation | 03/13/2026SE |
| K254052 | DAILIES TOTAL1®; DAILIES TOTAL1® MultifocalLPL · Traditional | Alcon Laboratories, Inc. | 02/13/2026SE |
| K251683 | Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking…LPL · Traditional | Bruno Vision Care, LLC | 12/23/2025SE |
| K250364 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens…LPL · Traditional | St. shine Optical Co., Ltd. | 10/07/2025SE |
| K244009 | Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily…LPL · Traditional | Yung Sheng Optical Co., Ltd. | 09/25/2025SE |
More from Yung Sheng Optical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K254269 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens…LPL · Traditional | 03/19/2026SE |
| K250364 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens…LPL · Traditional | 10/07/2025SE |
| K240477 | Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview…LPL · Traditional | 07/01/2024SE |
| K162317 | Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors…LPL · Traditional | 10/21/2016SE |
| K132146 | Saview-Aqua 58 UV (Etafilcon a) Visibility Tinted Soft (Hydrophilic) Contact Lens…LPL · Traditional | 08/30/2013SE |
| K121201 | Savie-Aqua 55UV (Methafilcon a) Tinnted Blue Soft (Hydrophilic) Contact LensLPL · Traditional | 10/26/2012SE |
| K092852 | Saview 58 UV; Toric & Multifocal (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily…LPL · Traditional | 03/11/2010SE |
| K030548 | Saview 55 Multifocal (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearLPL · Traditional | 04/04/2003SE |
| K021295 | Saview Toric 55 (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily WearLPL · Traditional | 06/04/2002SE |
| K020917 | Saview 55F (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily WearLPL · Traditional | 05/06/2002SE |
Questions and answers
When was Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal (Hefilcon A)Soft (Hydrophilic) Contact Lens cleared by the FDA?
Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal (Hefilcon A)Soft (Hydrophilic) Contact Lens (K123484) received a 510(k) decision of Substantially Equivalent on March 29, 2013, 136 days after the submission was received.
What is the product code of K123484?
The FDA product code is LPL – Lenses, Soft Contact, Daily Wear, a Class II (moderate risk) device regulated under 21 CFR 886.5925.