Massager, Vacuum, Light Induced Heating

Device Code: 5784

Product Code(s): NUV

Definition: THE DEVICE IS INTENDED TO TEMPORARILY ALTER THE APPEARANCE OF CELLULITE

Device Classification Information

Device Type ID5784
Device NameMassager, Vacuum, Light Induced Heating
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)
CFR Regulation Number878.4810 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNUV
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5784
DeviceMassager, Vacuum, Light Induced Heating
Product CodeNUV
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.
CFR Regulation Number878.4810 [🔎]
Premarket Reviews
ManufacturerDecision
BEIJING HONKON TECHNOLOGIES CO., LTD
 
SUBSTANTIALLY EQUIVALENT
1
I-TECH INDUSTRIES SRL
 
SUBSTANTIALLY EQUIVALENT
1
Device Problems
Adverse Event Without Identified Device Or Use Problem
2
Total Device Problems 2
TPLC Last Update: 2019-04-02 21:12:25

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