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510(k) Data Aggregation
K Number
K021936Device Name
MOIST PUNCTAL PLUG SYSTEM
Manufacturer
MOIST MEDICAL INC.
Date Cleared
2002-10-16
(126 days)
Product Code
LZU
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MOIST MEDICAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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
MOIST Punctal Plug System
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