Cleared Traditional

Hello,eyes? BIO Plug

K241229 · Bio Optics Co., Ltd. · Ophthalmic

Jun 2024

Decision

57d

Days

—

Risk

About This 510(k) Submission

K241229 is an FDA 510(k) clearance for the Hello,eyes? BIO Plug, a Plug, Punctum, submitted by Bio Optics Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on June 28, 2024, 57 days after receiving the submission on May 2, 2024. This device falls under the Ophthalmic review panel.

Submission Details

510(k) Number	K241229 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 2024
Decision Date	June 28, 2024
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF