Data / Medical devices / Canada / Kits Eyecare Ltd
Kits Eyecare Ltd: FDA-registered device maker in VANCOUVER British Columbia, Canada, 28 510(k) clearances and 4 PMA approvals
Kits Eyecare Ltd is registered with the FDA (registration 3017069344) in VANCOUVER British Columbia, Canada. It lists 6 device types. The FDA files 28 510(k) clearances and 4 PMA approvals under its listings, the newest dated April 25, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017069344
- Address
- 2955 Hebb Avenue, VANCOUVER British Columbia, Canada, V5M 4Y2
- Owner or operator
- KITS EYECARE LTD. (10050286)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- May 3, 2023
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Frame, Spectacle | HQZ | 1 | Exporter to the US | accessdata.fda.gov |
| Lens, Contact, (Disposable) | MVN | 2 | Exporter to the US | accessdata.fda.gov |
| Lens, Spectacle, Non-Custom (Prescription) | HQG | 1 | 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 |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | 1 | Exporter to the US, Manufacturer | 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 28, 2021 | K212806 | Alcon (serafilcon A) soft contact lenses for daily wear | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| 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 |
| July 15, 2020 | K201080 | Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens | LPL | Substantially Equivalent | Visco Vision, 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 |
| 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 |
| November 30, 2018 | K182249 | Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens | LPL | Substantially Equivalent | Bausch & Lomb, Incorporated | 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 20, 2018 | K180322 | Si-Hy (olifilcon B) color silicone hydrogel soft contact lens | LPL | Substantially Equivalent | Visco Vision, 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 |
| October 25, 2017 | K172600 | AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal | LPL | Substantially Equivalent | Alcon Laboratories, 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 |
| June 22, 2015 | K141348 | VISCO SOFT CONTACT LENS | LPL | Substantially Equivalent | Visco Vision, 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 |
| 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 |
| August 30, 2013 | K131378 | SUS (STENFILCON A) 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 |
| January 5, 2010 | K091339 | BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | 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 |
| May 16, 2002 | K020927 | BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS | LPL | Substantially Equivalent | Bausch & Lomb | 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 |
| October 11, 2001 | P010019 | FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES | LPM | 83 | May 29, 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 |
| December 16, 1996 | P960022 | SOFLENS66(TM) | LPM | 13 | April 8, 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
- All makers of Frame, Spectacle
- All makers of Sunglasses (Non-Prescription Including Photosensitive)
- All makers of Lens, Spectacle, Non-Custom (Prescription)
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.