Product Code: NXF FDA class 1 21 CFR 878.4810

Gas, Laser Generating

General, Plastic Surgery

The Gas, Laser Generating (product code NXF) refers to special laser gas mixtures used as a lasing medium in medical laser devices employed in surgical applications. It is classified as FDA Class 1, subject to general controls, and regulated under 21 CFR 878.4810 within the General and Plastic Surgery specialty. The device is not GMP-exempt and carries no implant or life-sustaining flags.

510(k)s
0
FEI Numbers
64
Registration Numbers
64
Unique Applicants
0
Years Active

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Basic Information

Product Code
NXF
Device Class
FDA class 1
Regulation Number
878.4810
Medical Specialty
General, Plastic Surgery
Review Panel
SU
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

Definition

Special laser gas mixtures used as a lasing medium

FEI Numbers

This FDA classification entry is associated with 64 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 64 registration numbers. Click on an entry to view related FDA registrations.