Data / Medical devices / Canada / Alcon Canada
Alcon Canada: FDA-registered device maker in Mississauga Ontario, Canada, 17 510(k) clearances and 1 PMA approval
Alcon Canada is registered with the FDA (registration 3003228982) in Mississauga Ontario, Canada. It lists 3 device types. The FDA files 17 510(k) clearances and 1 PMA approval under its listings, the newest dated September 15, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003228982
- Address
- 2665 Meadowpine Boulevard, Mississauga Ontario, Canada, L5N 8C7
- Owner or operator
- Alcon Laboratories, Inc. (1610287)
- Roles
- Exporter to the US
- First device listed
- August 13, 2013
- Registered through
- 2026
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 |
|---|---|---|---|---|---|---|
| September 15, 2022 | K222500 | AIR OPTIX COLORS | LPL | Substantially Equivalent | Alcon Laboratories, 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 |
| September 22, 2020 | K202448 | DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal | MVN | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| August 21, 2020 | K202036 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal | MVN | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| February 6, 2019 | K190045 | DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | 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 |
| August 3, 2018 | K181796 | FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| October 25, 2017 | K172600 | AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| November 30, 2016 | K161391 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| January 20, 2016 | K153643 | Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| January 20, 2016 | K153642 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| January 29, 2014 | K133176 | AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL | LPL | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| February 21, 2013 | K123994 | DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL | LPL | Substantially Equivalent | Ciba Vision Corporation | 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 |
| January 24, 2008 | K072777 | CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES | LPL | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| November 27, 1996 | K963487 | DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS | LPL | Substantially Equivalent | Ciba Vision Corporation | 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 |
|---|---|---|---|---|---|---|
| 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 Lenses, Soft Contact, Daily Wear
- All makers of Lens, Contact, (Disposable)
- All makers of Lenses, Soft Contact, Extended Wear
Updated May 29, 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.