Device, Analysis, Anterior Segment

Device Code: 4361

Product Code(s): MXK

Device Classification Information

Device Type ID4361
Device NameDevice, Analysis, Anterior Segment
Regulation DescriptionAC-powered Slitlamp Biomicroscope.
Regulation Medical SpecialtyOphthalmic
Review PanelOphthalmic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Diagnostic And Surgical Devices Branch (DSDB)
Submission Type510(k)
CFR Regulation Number886.1850 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMXK
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID4361
DeviceDevice, Analysis, Anterior Segment
Product CodeMXK
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAC-powered Slitlamp Biomicroscope.
CFR Regulation Number886.1850 [🔎]
Premarket Reviews
ManufacturerDecision
OCULUS OPTIKGERATE GMBH
 
SUBSTANTIALLY EQUIVALENT
1
SANTEC CORPORATION
 
SUBSTANTIALLY EQUIVALENT
1
Recalls
Manufacturer Recall Class Date Posted
1
Oculus Optikgeraete GMBH
II Feb-16-2018
TPLC Last Update: 2019-04-02 20:47:37

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