Bipolar HP AASR11021401

GUDID 17290110121607

ALMA LASERS LTD.

Radio-frequency skin contouring system
Primary Device ID17290110121607
NIH Device Record Key7b68fd87-a5d9-4435-b209-fe89437b866a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBipolar HP
Version Model Number1
Catalog NumberAASR11021401
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
GS117290110121607 [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 Date2018-09-24
Device Publish Date2018-08-22

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