Tabletop Sunlamp System

Device Code: 5914

Product Code(s): REH

Definition: A Sunlamp System That Sits On A Table, Primarily Intended To Tan The Face By Ultraviolet Radiation With Wavelengths In Air Between 200 And 400 Nanometers.

Device Classification Information

Device Type ID5914
Device NameTabletop Sunlamp System
Regulation DescriptionSunlamp Products And Ultraviolet Lamps Intended For Use In Sunlamp Products.
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)
CFR Regulation Number878.4635 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeREH
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5914
DeviceTabletop Sunlamp System
Product CodeREH
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSunlamp Products And Ultraviolet Lamps Intended For Use In Sunlamp Products.
CFR Regulation Number878.4635 [🔎]
TPLC Last Update: 2019-04-02 21:14:23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.