Data / Medical devices / United Kingdom / CooperVision Manufacturing, LTD.
CooperVision Manufacturing, LTD.: FDA-registered device maker in Wide Lane Southampton, United Kingdom, 16 510(k) clearances and 3 PMA approvals
CooperVision Manufacturing, LTD. is registered with the FDA (registration 3008586477) in Wide Lane Southampton, United Kingdom. It lists 4 device types. The FDA files 16 510(k) clearances and 3 PMA approvals under its listings, the newest dated November 15, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008586477
- Address
- Mountpark Unit 1, Wide Lane Southampton, United Kingdom, SO18 2FA
- Owner or operator
- COOPERVISION, INC. (9929062)
- Roles
- Repackager or relabeler
- First device listed
- April 27, 2006
- Registered through
- 2026
- Brand names listed
- Avaira (enfilcon A), Avaira (enfilcon A) Soft Contact Lens, BIOFINITY MULTIFOCAL, BIOFINITY TORIC, BIOFINITY TORIC MULTIFOCAL, BIOFINITY XR, Biofinity, Biofinity Energys and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia | QIT | 3 | Repackager or relabeler | accessdata.fda.gov |
| Lens, Contact, (Disposable) | MVN | 2 | Repackager or relabeler | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Lenses, Soft Contact, Extended Wear | LPM | 3 | Repackager or relabeler | 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 |
| May 19, 2000 | K001090 | METHAFILCON A | LPL | Substantially Equivalent | CooperVision, 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 |
| April 16, 1998 | K974408 | PROCLEAR (OMAFILCON A) DAILY WEAR CONTACT LENS | LPL | Substantially Equivalent | Biocompatibles Eyewear, 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 15, 2019 | P180035 | MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear | QIT | 34 | February 17, 2026 | accessdata.fda.gov |
| 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 Lenses, Soft Contact, Daily Wear
- All makers of Lens, Contact, (Disposable)
- All makers of Lenses, Soft Contact, Extended Wear
Updated February 17, 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.