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510(k) Data Aggregation
K Number
K112176Device Name
SILICONE SPHERES
Manufacturer
OCULO PLASTIK, INC.
Date Cleared
2011-09-15
(49 days)
Product Code
HPZ, EST
Regulation Number
886.3320Why did this record match?
Applicant Name (Manufacturer) :
OCULO PLASTIK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Silicone eye sphere implants are permanent implants that occupy the eye cavity when it becomes necessary to surgically remove the eye (enucleation), the contents of the eye sac (evisceration), or the space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis.
Device Description
Silicone eye sphere implants are permanent implants that occupy the eye cavity when it becomes necessary to surqically remove the eye (enucleation), the contents of the eve sac (evisceration), or the space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis. Silicone eye spheres have been used for decades and still are. As for any implant, spheres are single use. Users are ophthalmologists who are very qualified to use eve spheres. Furthermore, we provide instructions for use with each device. These instructions include: Description, Appearance, Indications, Silicone sphere, Mode of action, Contra-indications, Adverse effects, Recommendation for use, Precautions for use. They are available by units in a wide range of sizes, from 12 to 22mm.
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K Number
K073293Device Name
DURETTE IMPLANT
Manufacturer
OCULO PLASTIK, INC.
Date Cleared
2008-03-19
(117 days)
Product Code
HPZ
Regulation Number
886.3320Why did this record match?
Applicant Name (Manufacturer) :
OCULO PLASTIK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Durette ocular acrylic (PMMA) implants in 4 models are permanent implants that occupy the eye cavity when it becomes necessary to surgically remove the eye (enucleation), the contents of the eye sac (evisceration), or space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and to impart motion and stability to the eventual ocular prosthesis.
Device Description
The Durette Implant is an acrylic (PMMA) ocular implant available in 4 models. It is quasi-spherical with a smooth surface and a network of 20 interconnected tunnels in the anterior third for suturing muscles and tissue ingrowth. Each model has a slight off-center medial elongation. The models vary in the amount of anterior surface detail, ranging from as spherical as possible with a slight double radius front (#1), to having minute details (#2), low mounds (#3), and still higher mounds (#4). The implants are molded in 2 parts and welded together.
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K Number
K040689Device Name
EYE SPHERE IMPLANTS
Manufacturer
OCULO PLASTIK, INC.
Date Cleared
2004-06-10
(86 days)
Product Code
HPZ
Regulation Number
886.3320Why did this record match?
Applicant Name (Manufacturer) :
OCULO PLASTIK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Acrylic (PMMA) or Silicone eye sphere implants are permanent implants that occupy the eye cavity when it becomes necessary to surgically remove the eye (enucleation), or the space left after the removal of the contents of the eye ball (evisceration). It is used to replace volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis.
Device Description
Not Found
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