K241229
- 510(k) number
- K241229
- Device name
- Hello,eyes® BIO Plug
- Applicant
- Bio Optics Co., Ltd. KR
- Product code
- LZU — Plug, Punctum
- Decision date
- 2024-06-28
- Date received
- 2024-05-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K241229.pdf
Official FDA record: K241229
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.