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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
XAVIER A. GUERRA, OCULARIST, INC.
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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K Number
K970320Device Name
SCLERAL SHELL
Manufacturer
XAVIER A. GUERRA, OCULARIST, INC.
Date Cleared
1997-07-07
(160 days)
Product Code
HQT
Regulation Number
886.3800Why did this record match?
Applicant Name (Manufacturer) :
XAVIER A. GUERRA, OCULARIST, 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
SCLERAL SHELL, an ocular prosthesis, (artificial eye)
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