Aberrometer, Ophthalmic

Device Code: 4370

Product Code(s): NCF

Device Classification Information

Device Type ID4370
Device NameAberrometer, Ophthalmic
Regulation DescriptionOphthalmic Refractometer.
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) Exempt
CFR Regulation Number886.1760 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeNCF
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4370
DeviceAberrometer, Ophthalmic
Product CodeNCF
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOphthalmic Refractometer.
CFR Regulation Number886.1760 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
Alcon Research, Ltd.
II Aug-21-2017
TPLC Last Update: 2019-04-02 20:47:53

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