Search Results
Found 3 results
510(k) Data Aggregation
K Number
K003299Device Name
OPD-SCAN, MODELS ARK-10000 AND ARK-9000
Manufacturer
NIDEK CO., LTD.
Date Cleared
2001-03-09
(140 days)
Product Code
HLQ
Regulation Number
886.1350Why did this record match?
Product Code :
HLQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K973756Device Name
EYE SYS VISTA
Manufacturer
EYESYS TECHNOLOGIES, INC.
Date Cleared
1997-11-13
(42 days)
Product Code
HLQ
Regulation Number
886.1350Why did this record match?
Product Code :
HLQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Eyesys Uista has the Same intended use as other analysis and topography sustems. It specifically measures, records, and corneal arolyzes corneal curvature in a non-invasive manner.
The EyeSys Vista will be operated by dostors and technicians in ophtholmic and optometric offices . Corners topogital pho for potient screening become the standard of care documentation, corneal operative corneal surgery portu defermination and follow- up, as well as assisting in the and follow-up lenses. of contact
Device Description
Not Found
Ask a Question
K Number
K964290Device Name
EYECHEK
Manufacturer
REICHERT OPHTHALMIC INSTRUMENTS, DIV. LEICA, INC.
Date Cleared
1997-01-09
(73 days)
Product Code
HLQ
Regulation Number
886.1350Why did this record match?
Product Code :
HLQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1