Methafilcon a Soft Hydrophilic Contact Lenses, Frequency 55, Frequency 55 UV (to Be Marketed Yr. 2000), Frequency 55 Asp
FDA 510(k) K993252 · CooperVision, Inc.
510(k) numberK993252
Submission
- Device name
- Methafilcon a Soft Hydrophilic Contact Lenses, Frequency 55, Frequency 55 UV (to Be Marketed Yr. 2000), Frequency 55 Asp
- Applicant
- CooperVision, Inc.
Scottsville,, NY, US - Received
- September 28, 1999
- Decision date
- November 24, 1999
- 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 |
| 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 |
More from Innova Vision, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K234127 | Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact…LPL · Special | 01/25/2024SE |
| K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality…LPL · Special | 02/04/2022SE |
| K213164 | Avaira VitalityLPL · Special | 10/26/2021SE |
| K202756 | Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day…LPL · Special | 10/20/2020SE |
| K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A)…LPL · Traditional | 03/23/2020SE |
| K190965 | MyDayLPL · Special | 04/29/2019SE |
| K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV…LPL · Traditional | 12/11/2018SE |
| K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact LensLPL · Traditional | 07/13/2016SE |
| K133627 | Avaira Spheric and Toric (Enfilcon a) Soft Contact LensLPL · Special | 12/23/2013SE |
| K131378 | Sus (Stenfilcon a) Contact LensLPL · Traditional | 08/30/2013SE |
Questions and answers
When was Methafilcon a Soft Hydrophilic Contact Lenses, Frequency 55, Frequency 55 UV (to Be Marketed Yr. 2000), Frequency 55 Asp cleared by the FDA?
Methafilcon a Soft Hydrophilic Contact Lenses, Frequency 55, Frequency 55 UV (to Be Marketed Yr. 2000), Frequency 55 Asp (K993252) received a 510(k) decision of Substantially Equivalent on November 24, 1999, 57 days after the submission was received.
What is the product code of K993252?
The FDA product code is MVN – Lens, Contact, (Disposable), a Class II (moderate risk) device regulated under 21 CFR 886.5925.