FDA.reportPublic FDA data

510(k) K241229

Device
Hello,eyes® BIO Plug
Applicant
Bio Optics Co., Ltd.
510(k) number
K241229
Product code
LZU
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-28
Date received
2024-05-02
Classification name
Plug, Punctum
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SangHoon Jung
Address
A-1215, Skv1 Tower, 14, Galmachi-Ro 288beon-Gil, Jungwon-Gu Seongnam-Si KR 13201 13201

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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