Laser Assisted Lipolysis

Device Code: 5823

Product Code(s): ORK

Definition: Intended To Be Used For Laser Assisted Lipolysis

Device Classification Information

Device Type ID5823
Device NameLaser Assisted Lipolysis
Physical StateThe Device Is A Laser Module.
Technical MethodLaser Assisted Lipolysis Is A Procedure That Uses Laser Energy To Melt Small Volume Of Fat. The Fat Is Then Removed From The Body By Aspiration.
Target AreaA Small Volume (up To 120cc) Of Localized Deposits Of Fat Per Treatment Such As Chin Or Upper Arm (triceps)
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 CodeORK
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5823
DeviceLaser Assisted Lipolysis
Product CodeORK
FDA Device ClassificationClass 2 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 21:12:58

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