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510(k) Data Aggregation
K Number
K183173Device Name
LIGHTMED Ultrasound System
Manufacturer
Date Cleared
2019-07-01
(227 days)
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
Lightmed USA, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
LIGHTMED Ultrasound System is a non-invasion diagnostic ophthalmic ultrasound instrument specifically designed for measurements inside the ocular structures including orbital, anterior, posterior segment of eye and axial length for determination of IOL Power.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic
Device Description
The LIGHTMED Ultrasound System (model name: LIGHTSonic Ultrasound) is a portable ultrasound biometric ruler intended for use in ophthalmic applications. The system allows for the measurement of several key ocular features including axial length (AXL), anterior chamber depth. The device is used by coupling the probe / transducer to the eye either through direct contact or immersion methods. Available modes are A scan, biometric B-scan and UBM.
The A-scan mode of the system features a live A scan trace with storage for up to four scans. There are four (auto/manual) examination modes that use 9 different tissue velocities to calculate individual intraocular distances within the eye (AXL, ACD, Lens, and Vitreous). Other features include: post examination review of scans & measurement; four IOL formulas for lens power calculations; an immersion scanning capability for zero corneal compression of the eye while scanning and storage for up to five different user files.
The B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior-chamber of the eye, particularly when view of the chamber is obscured, such as is the case with cataracts.
The UBM mode can be used with a 35 MHz or a 50 MHz transducer. Because of the higher frequency of the transducer, it is expected that its greatest field of application will be in visualizing the anterior segment, because the focus area is about 11 mm from the transducer plane. The system will visualize other parts of the resolution is not as high. LIGHTMED Ultrasound System is a stand-alone system that runs on a Windows 10 platform and may be networked (by the user) for interface with electronic medical records systems, printing, and other purposes. The system consists of the console, ultrasound probe(s) and transducer, and foot pedal.
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K Number
K170761Device Name
LIGHTSonic BUBM
Manufacturer
Date Cleared
2018-04-13
(396 days)
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
Lightmed USA, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
LIGHTSonic B | UBM is a non-invasion diagnostic ophthalmic ultrasound instrument specifically designed for measurements inside the ocular structures including orbital, anterior and posterior segment of eye.
Device Description
The LIGHTMED Ultrasound System is a portable ultrasound biometric ruler intended for use in ophthalmic applications. The system allows for the measurement of several key ocular features including axial length (AXL), anterior chamber depth. The device is used by coupling the probe / transducer to the eye either through direct contact or immersion methods. Available modes are biometric B-scan and UBM. The B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior-chamber of the eye, particularly when view of the chamber is obscured, such as is the case with cataracts. The UBM mode can be used with a 35 MHz or a 50 MHz transducer. Because of the higher frequency of the transducer, it is expected that its greatest field of application will be in visualizing the anterior segment, because the focus area is about 11 mm from the transducer plane. The system will visualize other parts of the eye, but the resolution is not as high. LIGHTMED Ultrasound System is a stand-alone system that runs on a Windows 10 platform and may be networked (by the user) for interface with electronic medical records systems, printing, and other purposes. The system consists of the LIGHTSonic B|UBM console, ultrasound probe(s) and transducer, and foot pedal.
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Ask a specific question about this device
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