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Found 13 results
510(k) Data Aggregation
K Number
K170591Device Name
Altomed Malhotra Platinum Segments
Manufacturer
Altomed Limited
Date Cleared
2017-06-06
(98 days)
Product Code
MML
Regulation Number
886.5700Why did this record match?
Product Code :
MML
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Malhotra Platinum Segments are eyelid implants designed for the gravity-assisted treatment of lagophthalmos.
Device Description
Sterile, single use, eyelid weight implant segments, used to treat Lagophthalmos to weigh down the upper eye lid to aid closure, used in combinations to achieve optimum result for each patient. The devices are made of 90% platinum 10% iridium, an industry standard alloy utilized for eyelid implants. The segments are rectangular in shape, contoured to the shape of the eye, with suture holes for both linking segments together in a chain and securing segments into position. Two sizes of segments are provided, with total weight customized for patient need by surgeon selection of segment combinations. The min/max combination range is from total 0.4g to total 2.0g. They achieve their intended purpose through gravity, weighing down the upper eyelid.
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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?
Product Code :
MML
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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K Number
K021750Device Name
LID CHAIN EYELID WEIGHTS
Manufacturer
JEDMED INSTRUMENT CO.
Date Cleared
2003-01-27
(244 days)
Product Code
MML
Regulation Number
886.5700Why did this record match?
Product Code :
MML
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Restoration of dynamic lid closure in paralytic lagophthalmos due to facial nerve paralysis
Device Description
Lid Chain Eyelid Weight Implant
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K Number
K011740Device Name
CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)
Manufacturer
MEDDEV CORP.
Date Cleared
2001-07-02
(27 days)
Product Code
MML
Regulation Number
886.5700Why did this record match?
Product Code :
MML
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MedDev Contour Design Gold Eyelid Implants intended use is for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.
Device Description
MedDev's Contour Design Gold Eyelid Implants are spherically radiused parts of gold (at McdDCV S Ource) which conform to the curvature of the eye globe. They are available in twelve sizes ranging from 0.6 grams in 0.2-grams in 0.2-gram increments. All product tworo olzoo ranging trone or substantially equivalent to the predicated devices mentioned Specifications are the barns of Suzen the predicated MedDev devices and the proposed above. The occasion Gold Eyelid Implants is that the devices will now be supplied sterile to end users.
MedDev's Contour Design Gold Eyelid Implants can be implanted into the eyelid using the Medical techniques depicted in the product brochure. This technique is the same or substantially equivalent to techniques used for the predicated devices.
Implants are made of 99.99% pure gold. They are designed in a receinigular onapo with a opners spherical radius of 12.7 mm to conform to the shape of the good. The implant, allowing the surgeon to secure the implant to the tarsus or orbital septum.
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K Number
K011115Device Name
KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010
Manufacturer
HEINZ KURZ GMBH MEDIZINTECHNIK
Date Cleared
2001-05-02
(20 days)
Product Code
MML
Regulation Number
886.5700Why did this record match?
Product Code :
MML
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003646Device Name
SUTUREGROOVE WEIGHT SIZING SET
Manufacturer
IOP, INC.
Date Cleared
2001-02-22
(87 days)
Product Code
MML
Regulation Number
886.5700Why did this record match?
Product Code :
MML
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001123Device Name
KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111
Manufacturer
HEINZ KURZ GMBH MEDIZINTECHNIK
Date Cleared
2000-04-21
(14 days)
Product Code
MML
Regulation Number
886.5700Why did this record match?
Product Code :
MML
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994289Device Name
SUTUREGROOVE
Manufacturer
IOP, INC.
Date Cleared
2000-04-17
(118 days)
Product Code
MML
Regulation Number
886.5700Why did this record match?
Product Code :
MML
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SutureGroove Gold Eyelid Weights are indicated for the gravityassisted treatment of the functional defects of lagophthalmos resulting from facial paralysis. This is intended to protect against corneal exposure keratitis and improve cosmesis
Device Description
Not Found
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K Number
K000127Device Name
KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10
Manufacturer
HEINZ KURZ GMBH MEDIZINTECHNIK
Date Cleared
2000-04-12
(85 days)
Product Code
MML
Regulation Number
886.5700Why did this record match?
Product Code :
MML
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K990224Device Name
LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET
Manufacturer
LABTICIAN OPHTHALMICS, INC.
Date Cleared
1999-04-12
(77 days)
Product Code
MML
Regulation Number
886.5700Why did this record match?
Product Code :
MML
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Labtician Lid Load External Eyelid Sizing Weights are used by the physician to determine the correct gold eyelid weight to be implanted in the treatment of lagophthalmos.
Labtician Lid Load External Eyelid Sizing Weights are used by the physician who affixes a succession of external eyelid weights to the outer surface of the eyelid using until the proper eyelid closure is attained. Because the levator muscle seems to strengthen after the weight is added, the optimal weight for implantation is ususally that which holds lid about 1.0 mm lower than the normal lid as the patient looks straight ahead.
The corresponding implantable gold eyelid weight is then prescribed for implantation.
Sizing weights are not designed to be implanted, and are provided nonsterile and are re-usable following cleaning with soap and water and/or alcohol and rinsing with tap water.
Device Description
Labtician Lid Load External Eyelid Sizing Weights are spherically radiused strips of pure tantalum (99.5%), constructed in twelve sizes ranging from 0.6 grams to 2.8 grams in 0.2 gram increments.
A Labtician Lid Load External Eyelid Sizing Weight is attached to the outer skin of the upper eyelid with a double coated adhesive tape strip or other suitable adhesive.
The physical specifications and materials used in the construction of Labtician Iid Load External Eyelid Sizing Weights are identical to the EyeClose External Eyelid Weights, with the exception that Labtician Lid Load External Eyelid Sizing Weights are unpainted.
Labtician Lid Load External Eyelid Sizing Weights are constructed of pure tantalum (99.5%). The weights are designed in a rectangular shape with a spherical radius of curvature of 12.7 mm which conforms to the shape of the eye. All edges are smoothly rounded.
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