Data / Medical devices / South Korea / Joowon Innovation Co., Ltd.
Joowon Innovation Co., Ltd.: FDA-registered device maker in Cheonan-si, Seobuk-gu Chungnam, South Korea, 1 510(k) clearance
Joowon Innovation Co., Ltd. is registered with the FDA (registration 3012918760) in Cheonan-si, Seobuk-gu Chungnam, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 22, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012918760
- Address
- 44, Sureteo 1-gil, Cheonan-si, Seobuk-gu Chungnam, South Korea, 31074
- Owner or operator
- Joowon Innovation Co., Ltd. (10052639)
- Roles
- Manufacturer
- First device listed
- August 31, 2016
- Registered through
- 2026
- Brand names listed
- AQUA, Allure, BEYOND, Big Some Brown, Big Some Gray, COMPLEX 3CON GRAY, Chic Eye, Chic View 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 |
|---|---|---|---|---|---|---|
| August 22, 2016 | K161098 | ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) | LPL | Substantially Equivalent | Joowon Innovation Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 22, 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.