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510(k) Data Aggregation
K Number
K001234Device Name
BIOINSULATED SILICONE PUNCTUM PLUG
Manufacturer
Date Cleared
2000-07-11
(85 days)
Product Code
Regulation Number
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Applicant Name (Manufacturer) :
ADVANCED VISION SCIENCE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K980844Device Name
SURGIDEV SILICONE PUNCTUM PLUG
Manufacturer
Date Cleared
1998-05-11
(68 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ADVANCED VISION SCIENCE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Surgidev Silicone Punctum Plug is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex learing, itching or foreign body sensations which can be relieved by blockage of the punctum.
The Surgidev Sillcone Punctum Plug may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases such as comeal ulcers, conjunctivitis, pterygium, blepharitis, keratils, red lid margins, recurrent chalazions, recurrent comeal eroston, filamentry keratitis and other external eye diseases.
When indicated the Surgidev Silicone Puncture 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 ocular dryness secondary to contact lens use may also be alded by Slicone Puncturn Plugs.
Device Description
A flexible silicone ophthalmic device designed to fit and be retained in the punctum.
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