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510(k) Data Aggregation
K Number
K022836Device Name
STEPHENS DISPOSABLE SPECULUM
Manufacturer
STEPHENS INSTRUMENTS
Date Cleared
2002-11-01
(66 days)
Product Code
HNC
Regulation Number
886.4350Why did this record match?
Product Code :
HNC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Speculum made for single use in the retraction of eyelids in various ophthalmic procedures.
Device Description
A single use ophthalmic device designed to retract the eyelids.
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K Number
K981235Device Name
OCULOSTAT
Manufacturer
LASER CENTER DEV. CORP.
Date Cleared
1998-07-15
(103 days)
Product Code
HNC
Regulation Number
886.4350Why did this record match?
Product Code :
HNC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Oculostat is intended to reduce eye movement and stabilize the eye in any procedure in which the globe needs to be immobilized.
Device Description
The Oculostat by Laser Center Development Corporation consists of a scleral vacuum suction ring attached to a medical quality plastic ophihalmic speculum. After retracting the eyelids and inserting the lid margins into the speculum portion of the Oculostat, the suction-vacuum ring is attached to the sclera by sequentially contering, depressing, and enguing low vacuum (30mm Hg or less) by pump or spring-loaded syringe. The frictional forces between the eyelids and speculum, together with the vacuum ring, hold the eye steady despite extraocular muscle activity.
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K Number
K964289Device Name
EYE FIXATION SPECULUM
Manufacturer
EYEFIX, INC.
Date Cleared
1996-12-17
(50 days)
Product Code
HNC
Regulation Number
886.4350Why did this record match?
Product Code :
HNC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Eye Fixation Speculum, by eyeFix™, Inc. is intended to reduce eye movement and stabilize the eye in any procedure in which the globe needs to be immobilized. The device is provided sterile and is disposable for single use only.
Device Description
The Eye Fixation Speculum, by eyeFix, Inc., consists of a low profile scleral vacuum ring attached to a medical quality plastic ophthalmic speculum using a six-degrees of freedom resistance joint. After retracting the eyelids, and securing the speculum, the vacuum ring is attached to the sclera by locating the medical quality concentric elastomer-ring to the cornea. Vacuum is applied by way of the attached spring-loaded syringe. When vacuum is applied, the flexible elastomer portion of the ring sucks down on the scleral region of the eye securing the ring to the eye. The frictional forces within the resistance joint of the attaching arm of the speculum, together with the vacuum ring, hold the eye steady against the tendency of the eye muscles to the move the globe. Although this resistance is high enough to prevent the eye from moving, the force is not so high that the physician is prevented from conveniently moving the ring within the range of motion that the joint allows. Luminescent plastic on the upper portion of the ring helps in visualization of the eye under low examination lighting.
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