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Data / Medical devices / Canada / 1462287 BC Unlimited Liability Company

1462287 BC Unlimited Liability Company: FDA-registered device maker in Surry British Columbia, Canada, 14 510(k) clearances and 7 PMA approvals

1462287 BC Unlimited Liability Company is registered with the FDA (registration 3035373204) in Surry British Columbia, Canada. It lists 3 device types. The FDA files 14 510(k) clearances and 7 PMA approvals under its listings, the newest dated March 28, 2016. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this oneWatch 1462287 BC Unlimited Liability Company
FDA registration number
3035373204
Address
Unit # 192 St, Surry British Columbia, Canada, V3Z 6M3
Owner or operator
1462287 BC Unlimited Liability Company (10092334)
Roles
Exporter to the US, Repackager or relabeler
First device listed
December 24, 2024
Registered through
2026
Brand names listed
1 Day Acuvue Define 30 Pack, 1 Day Acuvue Define 90 Pack, 1 Day Acuvue Moist 30 Pack, 1 Day Acuvue Moist 90 Pack, 1 Day Acuvue Moist For Astigmatism 30 Pack, 1 Day Acuvue Moist For Astigmatism 90 Pack, 1 Day Acuvue Moist Multifocal 30 Pack, 1 Day Acuvue Moist Multifocal 90 Pack and more

Devices it lists

DeviceProduct codeClassRoleSource
Lens, Contact, (Disposable)MVN2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Lenses, Soft Contact, Daily WearLPL2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Lenses, Soft Contact, Extended WearLPM3Exporter to the US, Repackager or relabeleraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 28, 2016K160212ACUVUE (senofilcon C) Soft Contact LensLPLSubstantially EquivalentJohnson & Johnson Vision Care, Inc.accessdata.fda.gov
September 18, 2014K141670ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIALPLSubstantially EquivalentJohnson & Johnson Vision Care, Inc.accessdata.fda.gov
December 20, 2013K132715BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENSLPLSubstantially EquivalentBausch & Lomb, Incorporatedaccessdata.fda.gov
September 11, 2013K131208BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,LPLSubstantially EquivalentBausch & Lomb, Inc.accessdata.fda.gov
May 30, 2013K123202PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENSLPLSubstantially EquivalentCooperVision, Inc.accessdata.fda.gov
February 21, 2013K123994DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCALLPLSubstantially EquivalentCiba Vision Corporationaccessdata.fda.gov
June 5, 2012K113703BAUSCH + LOMB NESOFILCON A CONTACT LENSLPLSubstantially EquivalentBausch & Lomb, Incorporatedaccessdata.fda.gov
March 30, 2012K113168DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORICLPLSubstantially EquivalentCiba Vision Corporationaccessdata.fda.gov
March 3, 2008K073485VISTAKON (NARAFILCON) A SOFT CONTACT LENSLPLSubstantially EquivalentJohnson & Johnson Vision Care, Inc.accessdata.fda.gov
November 22, 2006K061948PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENSMVNSubstantially EquivalentCooperVision, Inc.accessdata.fda.gov
November 1, 2006K062614VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY)LPLSubstantially EquivalentJohnson & Johnson Vision Care, Inc.accessdata.fda.gov
March 28, 2005K050213FRESHLOOK ONE-DAY COLOR CONTACT LENSMVNSubstantially EquivalentCiba Vision Corporationaccessdata.fda.gov
October 28, 2004K042275VISTAKON (SENOFILCON A) SOFT CONTACT LENSLPLSubstantially EquivalentVistakonaccessdata.fda.gov
May 16, 2002K020608HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)LPLSubstantially EquivalentPoly Vue Technolgies, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
November 19, 2008P080011BIOFINITY (COMFILCON A)LPM201September 2, 2026accessdata.fda.gov
December 20, 2005P040045VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKERLPM143October 16, 2026accessdata.fda.gov
October 11, 2001P010019FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSESLPM83May 29, 2026accessdata.fda.gov
February 5, 1999P980006PURE VISION VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEARLPM35March 17, 2025accessdata.fda.gov
September 19, 1989P890023H55 HYDROPHILIC CONTACT LENSLPM53December 11, 2025accessdata.fda.gov
April 24, 1984P830037DURASOFT(R) 3 FOR EXT WEARLPM50November 8, 2012accessdata.fda.gov
March 18, 1980N18033ACUVUE CONTACT LENSLPM107April 17, 2026accessdata.fda.gov

Compare with other makers

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.