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510(k) Data Aggregation
K Number
K972034Device Name
MEDPOR OCULAR CONFORMER
Manufacturer
POREX SURGICAL, INC.
Date Cleared
1998-01-20
(232 days)
Product Code
HQN
Regulation Number
886.3130Why did this record match?
Product Code :
HQN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ophthalmic conformer is intended to be used as a post eye surgery device to prevent closure or adhesion during the healing process.
Device Description
An ophthalmic conformer is used after surgery on the eye to prevent closure or adhesion. It is a cup shaped device that is slipped between the orbit and the eye lid to cause separation. Its inner surface is formed to approximate the outer curvature of the eye. The ophthalmic conformer of this 510(k) is molded of Class VI. medical grade polymethyl methacrylate. It is sold in three sizes and it is sold non-sterile
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K Number
K970318Device Name
OCULAR CONFORMER
Manufacturer
SOUTHWEST ARTIFICIAL EYES, INC.
Date Cleared
1997-07-07
(160 days)
Product Code
HQN
Regulation Number
886.3130Why did this record match?
Product Code :
HQN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Conformer, is fabricated for the needs of a specific patient. Each is uniquely designed, fabricated, and fitted past-enucleation surgery, to maintain correct eye lid/socket configuration. In the other cases, to correct deformities of the eyelids, and/or socket. They are also fitted in a necessarily, sequential, increasing size, for infants afflicted with anophthalmia, or micro-ophthalmia, or in infants previous to the trauma or other socket and eyelid anomalies. Proper expansion therapy, with the use of sequential, increasing size conformers, is essential in eyelid development in infants and children.
Device Description
Not Found
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K Number
K970319Device Name
OCULAR CONFORMER
Manufacturer
XAVIER A. GUERRA, OCULARIST, INC.
Date Cleared
1997-07-07
(160 days)
Product Code
HQN
Regulation Number
886.3130Why did this record match?
Product Code :
HQN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Conformer, is fabricated for the needs of a The Custom specific patient. Each is uniquely designed, fabricated, and t fitted post-enucleation/evisceration surgery, to maintain correct eye lid/socket configuration. In the other cases, to correct deformities of the eyelids, and/or socket. They are also fitted in a necessarily, sequential, increasing size, for infants afflicted with anophthalmia, or micro-ophthalmia, as well as patients with trauma or other socket and eyelid anomalies. Proper expansion therapy, with the sential anomaries proper expansion chocariers, is essential in sequential, increasing Stac Controlmose), and eyelid development in infants and children.
Device Description
Not Found
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