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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
SOUTHWEST ARTIFICIAL EYES, INC.
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
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K Number
K970327Device Name
SCLERAL SHELL
Manufacturer
SOUTHWEST ARTIFICIAL EYES, INC.
Date Cleared
1997-07-07
(160 days)
Product Code
HQT
Regulation Number
886.3800Why did this record match?
Applicant Name (Manufacturer) :
SOUTHWEST ARTIFICIAL EYES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Custom Scleral Cover Shell, is an ocular prosthesis, (artificial eye), fitted over a deformed, or disfigured blind eye, or over an eviscerated globe, for a specific patient. Scleral Cover Shells are also indicated for patients with Microphthalmia, Phthisis Bulbi, or other types of eye deformities.
In cases of infants and children with microphthalmia, and /or anophthalmia, the orbital fascia, bony orbit, and palpebral fissures, will be provided with the volume and surface area necessary to develop more normally, thus avoiding the complication of future deformities and possible corrective surgery.
Device Description
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