Product Code: MVN
FDA class 2
21 CFR 886.5925
Lens, Contact, (Disposable)
Ophthalmic
Disposable Contact Lenses are single-use soft contact lenses designed for daily or extended wear, intended to correct refractive errors such as myopia, hyperopia, or astigmatism, and discarded after a specified wearing period rather than cleaned and reused. They are FDA Class 2, requiring 510(k) clearance, with product code MVN under 21 CFR 886.5925 in the Ophthalmic specialty. The device is not an implant and is not life-sustaining.
510(k)s
25
FEI Numbers
105
Registration Numbers
105
Unique Applicants
13
Years Active
22
Basic Information
- Product Code
- MVN
- Device Class
- FDA class 2
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 25 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K202448 | DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal | Sep 22, 2020 | Substantially Equivalent | Alcon Laboratories, Inc. |
| K202036 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal | Aug 21, 2020 | Substantially Equivalent | Alcon Laboratories, Inc. |
| 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 | Jun 15, 2015 | Substantially Equivalent | YUNG SHENG OPTICAL CO., LTD. |
| K143190 | Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens | Jan 16, 2015 | Substantially Equivalent | YUNG SHENG OPTICAL CO., LTD. |
| K130331 | SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER | Jul 26, 2013 | Substantially Equivalent | SAUFLON PHARMACEUTICALS, LTD. |
| K112192 | NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS | Oct 25, 2011 | Substantially Equivalent | BAUSCH & LOMB, INC. |
| K080632 | CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS | Oct 15, 2008 | Substantially Equivalent | CLEARLAB SG PTE LTD. |
| K080755 | SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS | Jun 10, 2008 | Substantially Equivalent | BAUSCH & LOMB, INC. |
| K073060 | CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Nov 29, 2007 | Substantially Equivalent | INNOVA VISION INC. |
| K061948 | PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS | Nov 22, 2006 | Substantially Equivalent | COOPERVISION, INC. |
| K061157 | SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS | Jun 22, 2006 | Substantially Equivalent | BAUSCH & LOMB |
| K052832 | SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES | May 15, 2006 | Substantially Equivalent | SAUFLON PHARMACEUTICALS, LTD. |
| K053191 | DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS | May 12, 2006 | Substantially Equivalent | INNOVA VISION INC. |
| K051900 | ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR | Aug 12, 2005 | Substantially Equivalent | JOHNSON & JOHNSON VISION CARE, INC. |
| K050065 | FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES | May 27, 2005 | Substantially Equivalent | CIBA VISION CORPORATION |
| K050213 | FRESHLOOK ONE-DAY COLOR CONTACT LENS | Mar 28, 2005 | Substantially Equivalent | CIBA VISION CORPORATION |
| K033701 | FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES | Dec 15, 2003 | Substantially Equivalent | CIBA VISION CORPORATION |
| K020389 | BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS | Jun 04, 2002 | Substantially Equivalent | OCULAR SCIENCES |
| K011718 | BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT | Jul 25, 2001 | Substantially Equivalent | BAUSCH & LOMB, INC. |
| K010636 | FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT | Mar 23, 2001 | Substantially Equivalent | CIBA VISION CORPORATION |
| K003826 | FOCUS DAILIES PROGRESSIVES | Mar 08, 2001 | Substantially Equivalent | CIBA VISION CORPORATION |
| K003586 | FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES | Feb 08, 2001 | Substantially Equivalent | CIBA-GEIGY CORP. |
| K993252 | METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP | Nov 24, 1999 | Substantially Equivalent | COOPERVISION, INC. |
| K992446 | DAILIES (NELFILCON A) ONE-DAY | Aug 18, 1999 | Substantially Equivalent | CIBA VISION JOHNS CREEK MFG. |
| K984273 | FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS | Jan 25, 1999 | Substantially Equivalent | CIBA VISION CORPORATION |
FEI Numbers
This FDA classification entry is associated with 105 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 105 registration numbers. Click on an entry to view related FDA registrations.