MVN · Lens, Contact, (Disposable)
Ophthalmic · 21 CFR 886.5925 · Class 2
Overview
| Product Code | MVN |
|---|---|
| Device Name | Lens, Contact, (Disposable) |
| Regulation | 21 CFR 886.5925 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.
Classification Rationale
(1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
Cleared Devices (25)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K202448 | DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal | Alcon Laboratories, Inc. | Sep 22, 2020 | SESE |
| K202036 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal | Alcon Laboratories, Inc. | Aug 21, 2020 | SESE |
| K150630 | 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 | Yung Sheng Optical Co., Ltd. | Jun 15, 2015 | SESE |
| K143190 | Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens | Yung Sheng Optical Co., Ltd. | Jan 16, 2015 | SESE |
| K130331 | SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER | Sauflon Pharmaceuticals, Ltd. | Jul 26, 2013 | SESE |
| K112192 | NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS | Bausch & Lomb, Inc. | Oct 25, 2011 | SESE |
| K080632 | CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS | Clearlab SG Pte, Ltd. | Oct 15, 2008 | SESE |
| K080755 | SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS | Bausch & Lomb, Inc. | Jun 10, 2008 | SESE |
| K073060 | CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Innova Vision, Inc. | Nov 29, 2007 | SESE |
| K061948 | PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS | CooperVision, Inc. | Nov 22, 2006 | SESE |
| K061157 | SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS | Bausch & Lomb | Jun 22, 2006 | SESE |
| K052832 | SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES | Sauflon Pharmaceuticals, Ltd. | May 15, 2006 | SESE |
| K053191 | DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS | Innova Vision, Inc. | May 12, 2006 | SESE |
| K051900 | ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR | Johnson & Johnson Vision Care, Inc. | Aug 12, 2005 | SESE |
| K050065 | FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES | Ciba Vision Corporation | May 27, 2005 | SESE |
| K050213 | FRESHLOOK ONE-DAY COLOR CONTACT LENS | Ciba Vision Corporation | Mar 28, 2005 | SESE |
| K033701 | FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES | Ciba Vision Corporation | Dec 15, 2003 | SESE |
| K020389 | BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS | Ocular Sciences | Jun 4, 2002 | SESE |
| K011718 | BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT | Bausch & Lomb, Inc. | Jul 25, 2001 | SESE |
| K010636 | FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT | Ciba Vision Corporation | Mar 23, 2001 | SESE |
| K003826 | FOCUS DAILIES PROGRESSIVES | Ciba Vision Corporation | Mar 8, 2001 | SESE |
| K003586 | FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES | Ciba-Geigy Corp. | Feb 8, 2001 | SESE |
| K993252 | METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP | CooperVision, Inc. | Nov 24, 1999 | SESE |
| K992446 | DAILIES (NELFILCON A) ONE-DAY | Ciba Vision Johns Creek Mfg. | Aug 18, 1999 | SESE |
| K984273 | FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS | Ciba Vision Corporation | Jan 25, 1999 | SESE |
Top Applicants
- Ciba Vision Corporation — 6 clearances
- Bausch & Lomb, Inc. — 3 clearances
- Yung Sheng Optical Co., Ltd. — 2 clearances
- Sauflon Pharmaceuticals, Ltd. — 2 clearances
- Innova Vision, Inc. — 2 clearances
