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510(k) Data Aggregation
K Number
K040912Device Name
HYDROGEL CANALICULAR PLUG
Manufacturer
PARTNERS IN BIOMATERIALS, INC.
Date Cleared
2004-11-16
(222 days)
Product Code
LZU
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PARTNERS IN BIOMATERIALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hydrogel Canalicular Plug is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching, or foreign body sensations, which can be relieved by blocking of the punctum.
The Hydrogel Canalicular Plug may be used in the treatment of dry eye syndrome and the dry eye component of various ocular surface diseases.
When indicated, the Hydrogel Canalicular Plug may be used after surgery of the eye to prevent complications due to dry eye and to enhance the retention of ocular medications on the eye. Patients experiencing dry eye related contact lens problems may also be aided by the Hydrogel Canalicular Plug.
Device Description
The Hydrogel Canalicular Plug is a very high water content hydrogel plug which, when exposed to lacrimal fluids, expands to approximately three times its size to form a gel which blocks the canaliculus. In its dry state, the Hydrogel Canalicular Plug measures approximately 0.3mm diameter by 2.5 mm long. It is supplied loaded in a disposable Inserter to assist the doctor in placement of the plug through the punctal opening. After the plug is inserted into the canaliculus, the dry hydrogel will absorb lacrimal fluids and swell. The fully hydrated plug has approximately a 95% water content. At this water content, the plug becomes a gel having about the same consistency as mucus. The gel easily deforms and takes the shape of the inside of the canaliculus.
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