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510(k) Data Aggregation
K Number
K050851Device Name
DELTA PUNCTUM PLUG
Manufacturer
Date Cleared
2005-08-19
(137 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DELTA LIFE SCIENCE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Punctum plugs are indicated for the treatment of dry eye disorder. A condition caused by insufficient moisture in the eye. As a result, one may experience some irritation and discomfort to the eyes. Patients that may benefit from the use of punctum plugs are: sufferers of allergies, cataracts, dry eye disorder secondary to contact lens use, and others who experience dry eye disorders. Specific treatment to stop the outflow of tears via a punctal opening (upper/lower) in order to increase tear flow on the surface of the eye.
Device Description
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