Search Results
Found 1 results
510(k) Data Aggregation
K Number
K061278Device Name
OPTYSE OPHTHALMOSCOPE
Manufacturer
OPHTHALMOS LTD.
Date Cleared
2006-05-16
(8 days)
Product Code
HLJ
Regulation Number
886.1570Why did this record match?
Applicant Name (Manufacturer) :
OPHTHALMOS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Optyse™ Lens Free Ophthalmoscope is a direct ophthalmoscope intended to be used by trained professionals to examine the fundus or the inside of the back of the eye.
Device Description
The Optyse™ is a compact battery-powered handheld direct ophthalmoscope for use by trained personnel for viewing the fundus or the inside of the back of the eye of a patient.
Ask a Question
Page 1 of 1