Product code MVN
- Device name
- Lens, Contact, (Disposable)
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.5925
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K202448 | DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal | Alcon Laboratories, Inc. | 2020-09-22 |
| K202036 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal | Alcon Laboratories, Inc. | 2020-08-21 |
| 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. | 2015-06-15 |
| K143190 | Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens | Yung Sheng Optical Co., Ltd. | 2015-01-16 |
| K130331 | SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER | Sauflon Pharmaceuticals, Ltd. | 2013-07-26 |
| K112192 | NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS | Bausch & Lomb, Inc. | 2011-10-25 |
| K080632 | CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS | Clearlab SG Pte, Ltd. | 2008-10-15 |
| K080755 | SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS | Bausch & Lomb, Inc. | 2008-06-10 |
| K073060 | CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Innova Vision, Inc. | 2007-11-29 |
| K061948 | PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS | CooperVision, Inc. | 2006-11-22 |
| K061157 | SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS | Bausch & Lomb | 2006-06-22 |
| K052832 | SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES | Sauflon Pharmaceuticals, Ltd. | 2006-05-15 |
| K053191 | DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS | Innova Vision, Inc. | 2006-05-12 |
| K051900 | ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR | Johnson & Johnson Vision Care, Inc. | 2005-08-12 |
| K050065 | FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES | Ciba Vision Corporation | 2005-05-27 |
| K050213 | FRESHLOOK ONE-DAY COLOR CONTACT LENS | Ciba Vision Corporation | 2005-03-28 |
| K033701 | FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES | Ciba Vision Corporation | 2003-12-15 |
| K020389 | BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS | Ocular Sciences | 2002-06-04 |
| K011718 | BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT | Bausch & Lomb, Inc. | 2001-07-25 |
| K010636 | FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT | Ciba Vision Corporation | 2001-03-23 |
| K003826 | FOCUS DAILIES PROGRESSIVES | Ciba Vision Corporation | 2001-03-08 |
| K003586 | FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES | Ciba-Geigy Corp. | 2001-02-08 |
| K993252 | METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP | CooperVision, Inc. | 1999-11-24 |
| K992446 | DAILIES (NELFILCON A) ONE-DAY | Ciba Vision Johns Creek Mfg. | 1999-08-18 |
| K984273 | FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS | Ciba Vision Corporation | 1999-01-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810040140006 | ZonedIn Contact Lenses | ZONEDIN VISION, LLC | 2019-12-04 |
| 10816816880524 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880654 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880647 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880630 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880623 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880616 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880609 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880593 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880586 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880579 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880562 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880555 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880548 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880531 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880517 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880500 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880494 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880487 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880470 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880463 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880456 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880449 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880432 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880425 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880418 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880401 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 10816816880395 | ProOcular Daily Disposable Contact Lens | CARLSBAD TECHNOLOGY INC. | 2016-10-28 |
| 08886428047368 | FreshKon® 1-Day (Etafilcon A) | OCULUS PRIVATE LIMITED | 2016-09-15 |
| 08886428047375 | FreshKon® 1-Day (Etafilcon A) | OCULUS PRIVATE LIMITED | 2016-09-15 |