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510(k) Data Aggregation
K Number
K981071Device Name
ML MICROKERATOMEManufacturer
Date Cleared
1998-07-23
(121 days)
Product Code
Regulation Number
886.4370Type
TraditionalPanel
OphthalmicReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The ML Microkeratome is used to perform lamellar keratoplasty procedures. This procedure is no I he ML MICrokeratome is used to perform athin circular corneal cap.
Device Description
Not Found
AI/ML Overview
I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the ML Microkeratome, acknowledging its substantial equivalence to a predicate device. It does not include details about device performance, specific acceptance criteria, study methodologies, or training data for AI models.
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K Number
K962661Device Name
ML MICROKERATOME BLADEManufacturer
Date Cleared
1996-12-09
(154 days)
Product Code
Regulation Number
886.4370Type
TraditionalPanel
OphthalmicReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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