Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear
FDA 510(k) K150630 · Yung Sheng Optical Co., Ltd.
510(k) numberK150630
Submission
- Device name
- Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear
- Applicant
- Yung Sheng Optical Co., Ltd.
Taichung City, TW - Received
- March 11, 2015
- Decision date
- June 15, 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 |
| K143190 | Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact LensMVN · Traditional | Yung Sheng Optical Co., Ltd. | 01/16/2015SE |
| 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 |
| K143190 | Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact LensMVN · Traditional | 01/16/2015SE |
| 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) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear cleared by the FDA?
Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear (K150630) received a 510(k) decision of Substantially Equivalent on June 15, 2015, 96 days after the submission was received.
What is the product code of K150630?
The FDA product code is MVN – Lens, Contact, (Disposable), a Class II (moderate risk) device regulated under 21 CFR 886.5925.