Data / Medical devices / South Korea / Vassen Co., Ltd.
Vassen Co., Ltd.: FDA-registered device maker in Pyeongtaek-si Gyeonggi, South Korea, 1 510(k) clearance
Vassen Co., Ltd. is registered with the FDA (registration 3008034930) in Pyeongtaek-si Gyeonggi, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 7, 2014. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008034930
- Address
- 50, Seotan-ro, Jinwi-myeon, Pyeongtaek-si Gyeonggi, South Korea, 17706
- Owner or operator
- Vassen Co., Ltd. (10047683)
- Roles
- Manufacturer
- First device listed
- October 20, 2014
- Registered through
- 2027
- Brand names listed
- 3D Colors, Beauteous, Celeb, Circle Venus, DAHAB, Eagle Eye, Elite, Eva Lens and more
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 |
|---|---|---|---|---|---|---|
| October 7, 2014 | K141699 | VASSEN COLOR | LPL | Substantially Equivalent | Vassen Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 7, 2014. 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.