Data / Medical devices / Canada / Optik K & R Inc.
Optik K & R Inc.: FDA-registered device maker in Toronto Ontario, Canada, 1 510(k) clearance
Optik K & R Inc. is registered with the FDA (registration 3004145084) in Toronto Ontario, Canada. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 2, 1994. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004145084
- Address
- 425 Midwest Road, Toronto Ontario, Canada, M1P3A6
- Owner or operator
- OPTIK K & R Inc. (10045451)
- Roles
- Contract manufacturer, Exporter to the US
- First device listed
- June 1, 2021
- Registered through
- 2027
- Brand names listed
- EYESPACE - SCLERAL, EYESPACE BESPOKE, FORGE, FORGE FORGE, MYOPIA MANAGEMENT MM (Myomedy), NIGHTLENS, NIGHTLENS NIGHTLENS, Ophthalmic Spectacle Frame and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Frame, Spectacle | HQZ | 1 | Exporter to the US | accessdata.fda.gov |
| Lens, Contact (Orthokeratology) | MUW | 2 | Contract manufacturer | accessdata.fda.gov |
| Lens, Contact (Other Material) - Daily | HQD | 2 | Contract manufacturer | accessdata.fda.gov |
| Lens, Contact (Polymethylmethacrylate) | HPX | U | Contract manufacturer | accessdata.fda.gov |
| Lens, Contact (Rigid Gas Permeable), Extended Wear | MWL | 3 | Contract manufacturer | accessdata.fda.gov |
| Lens, Contact, Orthokeratology, Overnight | NUU | 3 | Contract 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 |
|---|---|---|---|---|---|---|
| September 2, 1994 | K943753 | FRAME SPECTACLE | HQZ | Substantially Equivalent | Optic Tech Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Lens, Contact (Other Material) - Daily
- All makers of Lens, Contact (Rigid Gas Permeable), Extended Wear
- All makers of Lens, Contact (Orthokeratology)
- All makers of Lens, Contact, Orthokeratology, Overnight
- All makers of Frame, Spectacle
- All makers of Lens, Contact (Polymethylmethacrylate)
Updated September 2, 1994. 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.