Accent system AARF16091501SA0001

GUDID 17290110121683

ALMA LASERS LTD.

Ultrasonic body contouring system Ultrasonic body contouring system
Primary Device ID17290110121683
NIH Device Record Key450213d2-dd0a-4517-adec-7633206154f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccent system
Version Model Number1
Catalog NumberAARF16091501SA0001
Company DUNS532283264
Company NameALMA LASERS LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117290110121683 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NUVMassager, Vacuum, Light Induced Heating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-18
Device Publish Date2019-03-08

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