Data / Medical devices / South Korea / Mi Gwang Contact Lens Co., Ltd.
Mi Gwang Contact Lens Co., Ltd.: FDA-registered device maker in Gyeongsan-si Gyeongbuk, South Korea, 2 510(k) clearances
Mi Gwang Contact Lens Co., Ltd. is registered with the FDA (registration 9710495) in Gyeongsan-si Gyeongbuk, South Korea. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 27, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9710495
- FEI number
- 3003499948
- Address
- 693 Namcheon-ro Namcheon-myeon, Gyeongsan-si Gyeongbuk, South Korea, 38695
- Owner or operator
- MI GWANG CONTACT LENS CO., LTD. (9073780)
- Roles
- Manufacturer
- First device listed
- April 1, 2008
- Registered through
- 2026
- Brand names listed
- chromaview, clearcolor, clearcolor 1-day, clearcolor 1-day phantom, clearcolor phantom, eyedia clearcolor, eyedia clearcolor 1-day phantom, eyedia clearcolor CT 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 |
|---|---|---|---|---|---|---|
| September 27, 2019 | K192129 | ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens | LPL | Substantially Equivalent | Clearlab SG Pte, 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 27, 2019. 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.