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510(k) Data Aggregation
K Number
K140368Device Name
FAMILY OF DISPOSABLE LENSES
Manufacturer
SENSOR MEDICAL TECHNOLOGY, LLC
Date Cleared
2014-04-29
(74 days)
Product Code
HKS
Regulation Number
886.1660Why did this record match?
Product Code :
HKS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sensor Medical Technology Family of Disposable Lenses are a family of diagnostic and therapeutic contact lenses used in the examination of the eye fundus, retina and iridocorneal and vitreous bodies and for the laser therapy of intraocular abnormalities.
Device Description
The Sensor Medical Technology Family of Disposable Lenses is a family of diagnostic and therapeutic contact lenses use for eve examination and therapy of intraocular abnormalities. The Family consists of 14 lenses - 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mirror Lens, 3 Mirror Lens, Iridotomy Lens, Capsulotomy Lens, Retina 90 Lens, Retina 165 Lens, Retina 180 Lens, Indirect Lenses: 90 D, 78 D, 60 D, 28 D and 20 D.
The Family of Ophthalmic Lenses is designed around the classic Goldmann contact lens. Each model lens is of similar design, but provide different optical elements to provide excellent visualization of the ocular anatomical areas for the particular intended use. When used in conjunction with a slit lamp, the ophthalmic lenses provide a binocular and stereoscopic view of the specific optical region of the eye.
The lenses are provided sterile for single use.
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