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510(k) Data Aggregation
K Number
K150986Device Name
Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants
Manufacturer
MEDDEV CORPORATION
Date Cleared
2015-08-17
(125 days)
Product Code
MML
Regulation Number
886.5700Why did this record match?
Applicant Name (Manufacturer) :
MEDDEV CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MedDev Contour™ and ThinProfile™ Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.
Device Description
MedDev Contour™ and ThinProfile™ Eyelid Weight Implants were designed for the treatment of lagophthalmos, i.e. the inability of the eyelid to fully close. This condition is typically due to a degree of facial paralysis. The MedDev Contour™ and ThinProfile™ Eyelid Weight Implants are passive implants surgically placed in the eyelid. The density of their construct material (pure gold or platinum) provides the weight necessary to close the eyelid over the eye. The patient can use their functional orbital musculature to keep their eyes open, but have the gravitational assist from the Implant to close the eyelid.
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