Data / Medical devices / United Kingdom / CooperVision Manufacturing Ltd
CooperVision Manufacturing Ltd: FDA-registered device maker in Fareham Hampshire, United Kingdom, 15 510(k) clearances and 2 PMA approvals
CooperVision Manufacturing Ltd is registered with the FDA (registration 3006514242) in Fareham Hampshire, United Kingdom. It lists 3 device types. The FDA files 15 510(k) clearances and 2 PMA approvals under its listings, the newest dated December 11, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006514242
- Address
- Delta Park Concorde Way, Segensworth North, Fareham Hampshire, United Kingdom, PO15 5RL
- Owner or operator
- COOPERVISION, INC. (9929062)
- Roles
- Exporter to the US
- First device listed
- April 27, 2006
- Registered through
- 2026
- Brand names listed
- Avaira (enfilcon A), BIOFINITY MULTIFOCAL, BIOFINITY TORIC, BIOFINITY TORIC MULTIFOCAL, BIOFINITY XR, Biofinity, Biofinity Energys, Biofinity XR Multifocal and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact, (Disposable) | MVN | 2 | Exporter to the US | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Exporter to the US | accessdata.fda.gov |
| Lenses, Soft Contact, Extended Wear | LPM | 3 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 11, 2018 | K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| July 13, 2016 | K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| August 30, 2013 | K131378 | SUS (STENFILCON A) CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| August 5, 2013 | K130342 | SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER | LPL | Substantially Equivalent | Sauflon Pharmaceuticals, Ltd. | accessdata.fda.gov |
| July 26, 2013 | K130331 | SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER | MVN | Substantially Equivalent | Sauflon Pharmaceuticals, Ltd. | accessdata.fda.gov |
| May 30, 2013 | K123202 | PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| December 21, 2011 | K112302 | PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| September 29, 2008 | K081865 | PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| December 6, 2005 | K052560 | BIOFINITY (COMFILCON A) SOFT CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| November 7, 2003 | K032873 | PROCLEAR COMPATIBLES MULTIFOCAL | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| October 12, 2001 | K012425 | BIOMEDICS UV MULTIFOCAL | LPL | Substantially Equivalent | Ocular Sciences Puerto Rico, Inc. | accessdata.fda.gov |
| January 21, 1999 | K984046 | BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS | LPL | Substantially Equivalent | Ocular Sciences Puerto Rico, Inc. | accessdata.fda.gov |
| August 26, 1997 | K973063 | FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR | LPL | Substantially Equivalent | Aspect Vision Care, Ltd. | accessdata.fda.gov |
| August 20, 1997 | K972303 | OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS | LPL | Substantially Equivalent | Ocular Sciences Puerto Rico, Inc. | accessdata.fda.gov |
| April 3, 1997 | K970095 | PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS | LPL | Substantially Equivalent | Biocompatibles Eyewear, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 19, 2008 | P080011 | BIOFINITY (COMFILCON A) | LPM | 201 | September 2, 2026 | accessdata.fda.gov |
| January 31, 1986 | P850079 | HYDRASOFT (METHAFILCON B) CONTACT LENS | LPM | 82 | September 1, 2020 | accessdata.fda.gov |
Compare with other makers
- All makers of Lens, Contact, (Disposable)
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Lenses, Soft Contact, Extended Wear
Updated September 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.