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510(k) Data Aggregation
K Number
K241229Device Name
Hello,eyes® BIO Plug
Manufacturer
Bio Optics Co., Ltd.
Date Cleared
2024-06-28
(57 days)
Product Code
LZU
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Bio Optics Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hello,eyes® BIO Plug is intended to temporarily block tear drainage by the occlusion of the canaliculus in order to
- Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface diseases,
- Temporarily enhance the efficacy of topical medications or ocular lubricants,
- Temporarily treat contact lens intolerance secondary to dry eye,
- Temporarily treat dry eye after ocular surgery, and.
- Determine the potential effectiveness of permanent occlusion.
Device Description
Intracanalicular Plug named Hello,eyes@BIO Plug consists of lacrimal punctum plug and its holder. The plug is made of polydioxanone per 21 CFR 878.4840. The pigment for the violet dye is D&C Violet No.2 per 21 CFR 74.3602. It is 2.0mm long and available in three diameters: 0.3, 0.4, and 0.5mm which are based on USP synthetic absorbable suture diameters. Hello, eyes@ BIO Plug, the intracanalicular plug is a product sterile by ethylene oxide (EO) gas in accordance with ISO 11135:2014. It is designed to be inserted through the punctal opening and reside in the canaliculus until it is absorbed over time in tissue.
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