Hello,eyes® BIO Plug— 510(k) K241229

Substantially Equivalent

Bio Optics Co., Ltd.

FDA 510(k) clearance K241229 for Hello,eyes® BIO Plug, Substantially Equivalent on 2024-06-28. Applicant: Bio Optics Co., Ltd..

Clearance details

Applicant: Bio Optics Co., Ltd.
Product code: Code LZU
Advisory panel: Unknown
Date received: 2024-05-02
Decision date: 2024-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code LZU

product code LZU

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.