Gas, Laser Generating

Device Code: 5790

Product Code(s): NXF

Definition: Special Laser Gas Mixtures Used As A Lasing Medium

Device Classification Information

Device Type ID5790
Device NameGas, Laser Generating
Physical StateSpecial Laser Gas Mixtures Used As A Lasing Medium
Technical MethodSpecial Laser Gas Mixtures Used As A Lasing Medium
Target AreaSpecial Laser Gas Mixtures Used As A Lasing Medium
Regulation DescriptionLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type510(K) Exempt
CFR Regulation Number878.4810 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeNXF
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5790
DeviceGas, Laser Generating
Product CodeNXF
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.
CFR Regulation Number878.4810 [🔎]
TPLC Last Update: 2019-04-02 21:12:30

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