Data / Medical devices / South Korea / Bio Optics Co., Ltd.
Bio Optics Co., Ltd.: FDA-registered device maker in Seongnam Gyeonggi, South Korea, 1 510(k) clearance
Bio Optics Co., Ltd. is registered with the FDA (registration 3017609685) in Seongnam Gyeonggi, South Korea. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 28, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017609685
- Address
- 14, Galmachi-ro, 288beon-gil, Seongnam Gyeonggi, South Korea, 13201
- Owner or operator
- Bio Optics Co., Ltd. (10077954)
- Roles
- Manufacturer
- First device listed
- October 6, 2020
- Registered through
- 2026
- Brand names listed
- Hello, eyes - BIO Color Tear Test, Hello, eyes - BIO Surgical Knife, Hello,eyes (Bio Plug 0.3, Bio Plug 0.4, Bio Plug 0.5)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Knife, Ophthalmic | HNN | 1 | Manufacturer | accessdata.fda.gov |
| Plug, Punctum | LZU | U | Manufacturer | accessdata.fda.gov |
| Strip, Schirmer | KYD | 1 | 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 |
|---|---|---|---|---|---|---|
| June 28, 2024 | K241229 | Hello,eyes® BIO Plug | LZU | Substantially Equivalent | Bio Optics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated June 28, 2024. 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.