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510(k) Data Aggregation
K Number
K981640Device Name
S2LO
Manufacturer
ODYSSEY OPTICAL SYSTEMS, LLC.
Date Cleared
1998-08-05
(89 days)
Product Code
HLI, OBO
Regulation Number
886.1570Why did this record match?
Applicant Name (Manufacturer) :
ODYSSEY OPTICAL SYSTEMS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Odyssey Optical Systems S2LO is indicated for diagnosing and monitoring diseases and disorders that manifest themselves in the posterior pole of the eye.
Device Description
The S-LO is a medical imaging device utilizing three Class I lasers of different wavelengths (532 nm, 670 nm and 810 nm). Illumination from these lasers can be used independently or collectively to diagnose and monitor diseases and disorders of the posterior pole of the eye. The device operates on a 12 volt power supply and produces 0.8 mW/cm2 of retinal illumination. The non-invasive, non-contact S2LO allows imaging of the posterior segment of the human eye. High resolution images of the posterior segment of the eye can be captured, printed, stored electronically or transmitted for referral purposes.
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