Data / Medical devices / Canada / 4190777 Canada Inc
4190777 Canada Inc: FDA-registered device maker in Saint-Laurent Quebec, Canada, 2 510(k) clearances
4190777 Canada Inc is registered with the FDA (registration 3011302631) in Saint-Laurent Quebec, Canada. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated February 12, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011302631
- Address
- 4930 Chemin Bois-Franc, Saint-Laurent Quebec, Canada, H4S 1A7
- Owner or operator
- 4190777 CANADA INC (10047721)
- Roles
- Exporter to the US, Foreign private label distributor
- First device listed
- October 23, 2014
- Registered through
- 2026
- Brand names listed
- Activa Optimum 818 and 518, Sheerwave IPL 360, Spiritwave
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Exporter to the US, Foreign private label distributor | 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 |
|---|---|---|---|---|---|---|
| February 12, 2016 | K153718 | Spirit Hair Removal laser Family | GEX | Substantially Equivalent | Active Optical Systems , Ltd. | accessdata.fda.gov |
| April 29, 2005 | K050950 | MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS | GEX | Substantially Equivalent | Active Optical Systems, Ltd./Efraim Bidas | accessdata.fda.gov |
Compare with other makers
Updated February 12, 2016. 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.