Cleared Traditional

K241229 - Hello,eyes® BIO Plug (FDA 510(k) Clearance)

K241229 · Bio Optics Co., Ltd. · Ophthalmic device
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Jun 2024
Decision
57d
Days
-
Risk

K241229 is an FDA 510(k) clearance for the Hello,eyes® BIO Plug. Classified as Plug, Punctum (product code LZU).

Submitted by Bio Optics Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on June 28, 2024 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bio Optics Co., Ltd. devices

Submission Details

510(k) Number K241229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 110d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -