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510(k) Data Aggregation
K Number
K110129Device Name
RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION
Manufacturer
RIGHTMEDICAL PRODUCTS, LLC
Date Cleared
2011-08-30
(224 days)
Product Code
HJO, HJQ
Regulation Number
886.1850Why did this record match?
Applicant Name (Manufacturer) :
RIGHTMEDICAL PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Righton Zoom Slit Lamp NS-2D with photo option is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
Device Description
The NS-2D zoom slit lamps are designed for ophthalmic observation and microphotography. These slit lamps feature zoom stereoscopic converging microscopes that can be used for ophthalmic observation. Each instrument consists primarily of the main unit and the illumination power supply unit.
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K Number
K060869Device Name
RS-1000 ZOOM SLITLAMP WITH OPTION
Manufacturer
RIGHTMEDICAL PRODUCTS, LLC
Date Cleared
2006-05-11
(42 days)
Product Code
HJO
Regulation Number
886.1850Why did this record match?
Applicant Name (Manufacturer) :
RIGHTMEDICAL PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RS-1000 Zoom Slitlamp with option is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
Device Description
The RS-1000 Zoom slitlamp microscope consists of a microscope with a halogen lamp which illuminates the inner eye for examination with an optional attachment for photographic or video capabilities and an illumination power supply.
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