Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens
FDA 510(k) K143190 · Yung Sheng Optical Co., Ltd.
510(k) numberK143190
Submission
- Device name
- Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens
- Applicant
- Yung Sheng Optical Co., Ltd.
Taichung City, TW - Received
- November 5, 2014
- Decision date
- January 16, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MVN – Lens, Contact, (Disposable)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5925
- Specialty
- Ophthalmic
Other 510(k)s with product code MVN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261812 | HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina…MVN · Special | HOYA Lamphun , Ltd. | 07/07/2026SE |
| K202448 | DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP MultifocalMVN · Special | Alcon Laboratories, Inc. | 09/22/2020SE |
| K202036 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…MVN · Special | Alcon Laboratories, Inc. | 08/21/2020SE |
| K150630 | Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear…MVN · Traditional | Yung Sheng Optical Co., Ltd. | 06/15/2015SE |
| K130331 | Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens…MVN · Traditional | Sauflon Pharmaceuticals, Ltd. | 07/26/2013SE |
| K112192 | Naturelle Daily Disposable (Hilafilcon B) Cosmetically Tinted Contact LensMVN · Special | Bausch & Lomb, Inc. | 10/25/2011SE |
| K080632 | CLEAR1-DAY Hioxifilcon Daily Disposable Soft Contact LensMVN · Traditional | Clearlab SG Pte, Ltd. | 10/15/2008SE |
| K080755 | Soflens Daily Disposable Toric (Hilafilcon B) Visibility Tinted Contact LensMVN · Traditional | Bausch & Lomb, Inc. | 06/10/2008SE |
| K073060 | Calaview (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearMVN · Special | Innova Vision, Inc. | 11/29/2007SE |
| K061948 | Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact LensMVN · Traditional | CooperVision, Inc. | 11/22/2006SE |
More from CooperVision, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K244009 | Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily…LPL · Traditional | 09/25/2025SE |
| K232839 | Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft…LPL · Traditional | 12/16/2024SE |
| K223585 | Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily…LPL · Traditional | 12/20/2023SE |
| K213983 | Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily WearLPL · Traditional | 09/02/2022SE |
| K151586 | Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact LensLPL · Traditional | 08/10/2015SE |
| K150630 | Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear…MVN · Traditional | 06/15/2015SE |
| K143052 | Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily;Eye…LPL · Traditional | 12/16/2014SE |
| K133735 | Eye Secret 55 UV Aspheric (Methafilcon a) Soft (Hydrophilic) Contact LensLPL · Traditional | 03/21/2014SE |
| K132854 | Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact Lens for Daily WearLPL · Traditional | 12/23/2013SE |
Questions and answers
When was Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens cleared by the FDA?
Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens (K143190) received a 510(k) decision of Substantially Equivalent on January 16, 2015, 72 days after the submission was received.
What is the product code of K143190?
The FDA product code is MVN – Lens, Contact, (Disposable), a Class II (moderate risk) device regulated under 21 CFR 886.5925.