Data / Medical devices / Costa Rica / CooperVision Manufacturing Costa Rica SRL
CooperVision Manufacturing Costa Rica SRL: FDA-registered device maker in Alajuela, Costa Rica, 3 510(k) clearances
CooperVision Manufacturing Costa Rica SRL is registered with the FDA (registration 3012123291) in Alajuela, Costa Rica. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 25, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012123291
- Address
- Zona Franca El Coyol - Building 53, Alajuela, Costa Rica, 20101
- Owner or operator
- COOPERVISION, INC. (9929062)
- Roles
- Manufacturer
- First device listed
- January 18, 2019
- Registered through
- 2026
- Brand names listed
- Clariti 1 Day, Clariti 1 Day Multifocal, Clariti 1 Day Toric
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact, (Disposable) | MVN | 2 | Manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | 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 |
|---|---|---|---|---|---|---|
| January 25, 2024 | K234127 | Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| October 20, 2020 | K202756 | Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) | LPL | Substantially Equivalent | CooperVision, 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 |
Compare with other makers
Updated January 25, 2024. 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.