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510(k) Data Aggregation
K Number
K233516Device Name
Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)
Manufacturer
Reichert, Inc.
Date Cleared
2024-05-01
(182 days)
Product Code
HKY
Regulation Number
886.1930Why did this record match?
Applicant Name (Manufacturer) :
Reichert, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes is intended to be used for the measurement of intraocular pressure of the human eye.
Device Description
The Reichert Tono-Vera® Tonometer is a hand-held, battery powered instrument that utilizes rebound methodology to measure the intraocular pressure (IOP) of the eye. The tonometer propels a small, plastic-tipped measurement probe in a controlled manner against a patient's unanesthetized eye in order to calculate IOP. The device has a simple, four-button control system and an LCD that provides information to the operator and displays measurement results.
There are two Tono-Vera Tonometer models:
· Tono-Vera Tonometer Starter Kit, AA Battery, Model 16305; and
• Tono-Vera Tonometer Starter Kit, Rechargeable, Model 16306.
Both models of the Tono-Vera Tonometer have a required accessory, the Ocu-Dot® Tonometer Probe, model 16318. The Ocu-Dot Tonometer Probe is a sterile, single-use, disposable accessory.
The Tono-Vera Tonometer utilizes a camera-based alignment system, called ActiView™ to improve alignment with the apex of the cornea and reduce measurement variability caused by operator technique. The measuring process starts automatically once alignment conditions are fulfilled.
The device has two measurement options: 3+ (Quick) Measurement Option and 6 Measurement Option. Both the 3+ (Quick) Measurement Option and 6 Measurement Option use the same calculation for the IOP result. The 3+ (Quick) Option can calculate a final IOP result with as few as three measurements. The 6 Measurement Option always uses six measurements to calculate the final IOP result.
The Tono-Vera Tonometer can be connected to a computer with ReichertSync® installed on it. Data from ReichertSync can be imported by an EMR system.
The Tono-Vera Tonometer determines IOP by detecting and analyzing the motion of the measurement probe as it briefly contacts the cornea.
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K Number
K141954Device Name
XCEL 455 SLIT LAMP
Manufacturer
REICHERT, INC.
Date Cleared
2014-10-15
(89 days)
Product Code
HJO
Regulation Number
886.1850Why did this record match?
Applicant Name (Manufacturer) :
REICHERT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Xcel 455 Slit Lamp is an AC-powered slit lamp biomicroscope that is intended for use in examining the anterior eye segment, from the corneal 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 segment of the eye.
Device Description
The Xcel 455 slit lamp is a general purpose examination instrument used in a wide range of eye care practices. Slit lamps are used for ophthalmic observation of the structures of the eye. By controlling the light source, nature of slit, and filters, physicians, optometrists, ophthalmologists and eye care technicians can observe various structures in the eye. The Xcel 455 can be used on any patient; there are no contraindications.
Ophthalmic slit lamp design has not changed in decades, and like most, including the predicate Xcel 255, the Xcel 455 slit lamp consists of two fundamental subsystems, the illumination source to illuminate the eye to be examined, and the microscope to enable the practitioner to view the structures of the eye under magnification.
The Xcel 455 uses a low voltage (6 Volt, 20 Watt) dimmable halogen lamp, and a selection of 4 color filters, or none, to illuminate the eye. The device uses a stereo microscope with 5 selections of magnification ranges, from 6.5x to 40x, to view the structure. There is a mount that allows other devices to attach in line with the optical path, such as a prism type contact tonometer.
Like the predicate Xcel 255 device, the Xcel 455 device uses a steel body and glass lenses. The scientific principle of all slit lamps is to project light onto a patient's eye, so that a doctor may view the eye and its structures through a microscope.
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K Number
K071839Device Name
SOCT COPERNICUS, MODEL 15205
Manufacturer
REICHERT, INC.
Date Cleared
2008-02-27
(237 days)
Product Code
OBO, HLI
Regulation Number
886.1570Why did this record match?
Applicant Name (Manufacturer) :
REICHERT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An optical coherence tomography system indicated for the in vivo imaging and measurement of the retina as an aid in the diagnosis and management of retinal diseases.
Device Description
The SOCT Copernicus is an AC-powered device containing illumination and viewing optics intended to examine the retina of the eye. The SOCT Copernicus consists of a main unit, which houses the optical system used for imaging the retina, the light source, and a power supply. In addition, both systems utilize a chin rest/forehead rest assembly for patient interface and a computer with software for data analysis / image processing.
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K Number
K070534Device Name
MODIFICATION TO: OCU-FILM TIP COVER
Manufacturer
REICHERT, INC.
Date Cleared
2007-03-27
(29 days)
Product Code
HKY
Regulation Number
886.1930Why did this record match?
Applicant Name (Manufacturer) :
REICHERT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ocu-Film Tip Cover is intended to be used to protect the Tono-Pen transducer from dust and fluids, and helps protect patients from risk of cross-contamination.
Device Description
Ocu-Film Tip Cover
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K Number
K061330Device Name
PSL PORTABLE SLIT LAMP
Manufacturer
REICHERT, INC.
Date Cleared
2006-05-25
(13 days)
Product Code
HJO
Regulation Number
886.1850Why did this record match?
Applicant Name (Manufacturer) :
REICHERT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A slitlamp biomicroscope is intended for use in eye examination of - the anterior 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
Not Found
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