Data / Medical devices / South Korea / Vision Science Co., Ltd.
Vision Science Co., Ltd.: FDA-registered device maker in Daegu, South Korea, 2 510(k) clearances
Vision Science Co., Ltd. is registered with the FDA (registration 3006946962) in Daegu, South Korea. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 26, 2016. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3006946962
- Address
- 37-38, Maeyeo-ro 1-gil Dong-gu, Daegu, South Korea, 41059
- Owner or operator
- VISION SCIENCE CO., LTD. (10046391)
- Roles
- Manufacturer
- First device listed
- March 17, 2014
- Registered through
- 2026
- Brand names listed
- AMARA CONTACT LENS, Amara Lens, Another Me Kristin, Attention-Plz Kristin, Barris Land, Day n' Night Kristin, Debut Kristin, Dimple Color 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 26, 2016 | K161124 | EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear | LPL | Substantially Equivalent | Vision Science Co., Ltd. | accessdata.fda.gov |
| March 5, 2014 | K132714 | ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR, TINTED, AND COSMETIC TINTED) | LPL | Substantially Equivalent | Vision Science Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 26, 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.