Data / Medical devices / United Kingdom / LENS GLOBAL Limited
LENS GLOBAL Limited: FDA-registered device maker in Chesham Buckinghamshire, United Kingdom, 26 510(k) clearances and 2 PMA approvals
LENS GLOBAL Limited is registered with the FDA (registration 3011649033) in Chesham Buckinghamshire, United Kingdom. It lists 3 device types. The FDA files 26 510(k) clearances and 2 PMA approvals under its listings, the newest dated November 29, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011649033
- Address
- Unit 9 Howard Industrial Estate; Chilton Road, Chesham Buckinghamshire, United Kingdom, HP5 2AU
- Owner or operator
- Lensglobal (10049510)
- Roles
- Exporter to the US
- First device listed
- June 10, 2015
- Registered through
- 2026
- Brand names listed
- AIR OPTIX Hydraglyde, AIR OPTIX hydraglyde for astigmatism, Acuvue 2 6 pack, Acuvue Moist, Acuvue Moist for Astigmatism, Acuvue Oasys, Acuvue Oasys 1 day astigmatism, Acuvue Oasys Max 1 Day 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 |
|---|---|---|---|---|---|---|
| November 29, 2021 | K210930 | ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| April 12, 2021 | K210436 | Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| October 20, 2020 | K202756 | Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| June 2, 2020 | K200528 | Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism | LPL | Substantially Equivalent | Bausch + Lomb, Incorporated | accessdata.fda.gov |
| January 18, 2019 | K182782 | DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| December 11, 2018 | K182902 | Precision1 | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| 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 |
| August 3, 2018 | K181796 | FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| April 10, 2018 | K180299 | ACUVUE OASYS (senofilcon A) with Photochromic Additive | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| July 13, 2016 | K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| March 28, 2016 | K160212 | ACUVUE (senofilcon C) Soft Contact Lens | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| February 11, 2016 | K151918 | Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist | LPL | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| January 20, 2016 | K153643 | Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| February 13, 2015 | K143632 | Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens | LPL | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| September 18, 2014 | K141670 | ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| May 30, 2013 | K123202 | PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| March 30, 2012 | K113168 | DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC | LPL | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| November 22, 2006 | K061948 | PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS | MVN | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| November 1, 2006 | K062614 | VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| June 22, 2006 | K061157 | SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS | MVN | Substantially Equivalent | Bausch & Lomb | accessdata.fda.gov |
| December 6, 2005 | K052560 | BIOFINITY (COMFILCON A) SOFT CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| March 28, 2005 | K050213 | FRESHLOOK ONE-DAY COLOR CONTACT LENS | MVN | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| October 28, 2004 | K042275 | VISTAKON (SENOFILCON A) SOFT CONTACT LENS | LPL | Substantially Equivalent | Vistakon | accessdata.fda.gov |
| February 26, 2002 | K013973 | ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC | LPL | Substantially Equivalent | Vistakon | accessdata.fda.gov |
| March 6, 2000 | K000384 | FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX | LPL | Substantially Equivalent | CooperVision, 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 |
|---|---|---|---|---|---|---|
| December 20, 2005 | P040045 | VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER | LPM | 143 | October 16, 2026 | accessdata.fda.gov |
| October 11, 2001 | P010019 | FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES | LPM | 83 | May 29, 2026 | 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 October 16, 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.