Data / Medical devices / United Kingdom / Arcadant B.V.
Arcadant B.V.: FDA-registered device maker in LIskeard Cornwall, United Kingdom, 3 510(k) clearances
Arcadant B.V. is registered with the FDA (registration 3014054090) in LIskeard Cornwall, United Kingdom. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 6, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014054090
- Address
- prince albert house liskeard business park, LIskeard Cornwall, United Kingdom, PL14 3US
- Owner or operator
- arcadant b.v. (10056015)
- Roles
- Exporter to the US
- First device listed
- November 16, 2017
- Registered through
- 2026
- Brand names listed
- CHROMAVIEW EYEFX, chromaview
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
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 6, 2018 | K181558 | Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens | LPL | Substantially Equivalent | Gelflex Laboratories | accessdata.fda.gov |
| August 22, 2016 | K161098 | ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) | LPL | Substantially Equivalent | Joowon Innovation Co., Ltd. | accessdata.fda.gov |
| March 10, 2006 | K051477 | MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC) | LPL | Substantially Equivalent | Mi Gwang Contact Lens Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 6, 2018. 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.