Electrosurgical, Radio Frequency, Refractive Correction

Device Code: 4445

Product Code(s): MWD

Device Classification Information

Device Type ID4445
Device NameElectrosurgical, Radio Frequency, Refractive Correction
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 TypePMA
FDA Device ClassificationClass 3 Medical Device
Product CodeMWD
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4445
DeviceElectrosurgical, Radio Frequency, Refractive Correction
Product CodeMWD
FDA Device ClassificationClass 3 Medical Device
TPLC Last Update: 2019-04-02 20:49:18

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