Data / Medical devices / Canada / Imperial Optical, Inc
Imperial Optical, Inc: FDA-registered device maker in Town Of Mount Royal, Quebec, Canada, 18 510(k) clearances and 3 PMA approvals
Imperial Optical, Inc is registered with the FDA (registration 3012138439) in Town Of Mount Royal, Quebec, Canada. It lists 3 device types. The FDA files 18 510(k) clearances and 3 PMA approvals under its listings, the newest dated November 16, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012138439
- Address
- 380 Lazard Ave., Town Of Mount Royal, Quebec, Canada, H3R 1P3
- Owner or operator
- 2745-3083 QUEBEC, INC. (9001572)
- Roles
- Exporter to the US
- First device listed
- June 14, 2016
- Registered through
- 2027
- Brand names listed
- Acuvue, Precision, Precsion1, Ultra
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 16, 2023 | K232921 | DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric | 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 |
| 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 29, 2014 | K133176 | AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL | LPL | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| December 20, 2013 | K132715 | BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS | LPL | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| September 11, 2013 | K131208 | BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, | LPL | Substantially Equivalent | Bausch & Lomb, Inc. | 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 |
| February 21, 2013 | K123994 | DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL | LPL | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| June 5, 2012 | K113703 | BAUSCH + LOMB NESOFILCON A CONTACT LENS | LPL | Substantially Equivalent | Bausch & Lomb, Incorporated | 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 |
| 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 |
| October 28, 2004 | K042275 | VISTAKON (SENOFILCON A) SOFT CONTACT LENS | LPL | Substantially Equivalent | Vistakon | accessdata.fda.gov |
| May 16, 2002 | K020927 | BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS | LPL | Substantially Equivalent | Bausch & Lomb | accessdata.fda.gov |
| February 23, 2000 | K994324 | ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER | LPL | Substantially Equivalent | Vistakon, Johnson & Johnson Vision Products, 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 |
|---|---|---|---|---|---|---|
| April 25, 2023 | P220007 | Precision7; Precision7 for Astigmatism; Precision7 Multifocal; Precision7 Multifocal Toric (serafilcon A) Soft Conta | LPM | 7 | March 11, 2026 | accessdata.fda.gov |
| February 5, 1999 | P980006 | PURE VISION VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEAR | LPM | 35 | March 17, 2025 | accessdata.fda.gov |
| March 18, 1971 | N16895 | SOFLENS CONTACT LENSES (POLYMACON) | LPM | 96 | October 24, 2025 | 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 March 11, 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.