Data / Medical devices / Canada / Alliance Optical Group ULC
Alliance Optical Group ULC: FDA-registered device maker in Montreal Quebec, Canada, 17 510(k) clearances and 1 PMA approval
Alliance Optical Group ULC is registered with the FDA (registration 3006297986) in Montreal Quebec, Canada. It lists 5 device types. The FDA files 17 510(k) clearances and 1 PMA approval under its listings, the newest dated November 30, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006297986
- Address
- 5100 de la Savane, Suite 100, Montreal Quebec, Canada, H4T 1P8
- Owner or operator
- Alliance Optical Group ULC (10024581)
- Roles
- Exporter to the US
- First device listed
- May 22, 2008
- Registered through
- 2026
- Brand names listed
- Fendi optical frames, Metal and Plastic Optical Frames, Sunglasses
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 |
| 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 | 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 30, 2018 | K182249 | Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens | LPL | Substantially Equivalent | Bausch & Lomb, Incorporated | 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 |
| August 30, 2013 | K131378 | SUS (STENFILCON A) CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| May 30, 2013 | K123202 | PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| June 5, 2012 | K113703 | BAUSCH + LOMB NESOFILCON A CONTACT LENS | LPL | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| December 21, 2011 | K112302 | PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES | LPL | Substantially Equivalent | CooperVision, Inc. | 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 |
| 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 |
| April 26, 2002 | K020392 | FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| May 31, 1996 | K960818 | SUNGLASSES | HQY | Substantially Equivalent | Visard Srl | accessdata.fda.gov |
| July 12, 1995 | K953002 | METAL FRAM WITH POLYCARBONATE LENS | HQY | Substantially Equivalent | Nakanishi Optical Products Corp. | accessdata.fda.gov |
| October 1, 1993 | K933733 | MARCHON/MARCOLIN EYEGLASSES | HQZ | Substantially Equivalent | Marchon Eyewear, Inc. | accessdata.fda.gov |
| September 20, 1993 | K933734 | MARCHON/MARCOLIN SUNGLASSES | HQY | Substantially Equivalent | Marchon 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 |
|---|---|---|---|---|---|---|
| February 5, 1999 | P980006 | PURE VISION VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEAR | LPM | 35 | March 17, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Sunglasses (Non-Prescription Including Photosensitive)
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Lens, Contact, (Disposable)
- All makers of Lenses, Soft Contact, Extended Wear
- All makers of Frame, Spectacle
Updated March 17, 2025. 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.