BLISS SYSTEM

GUDID 07290016541632

The Venus Bliss device is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the Venus Bliss device is intended for the treatment of the following medical conditions; using the MP2 applicator for delivery of RF energy combined with massage and magnetic field pulses: • Relief of minor muscle aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation • Temporary reduction in the appearance of cellulite

VENUS CONCEPT LTD

Low-intensity laser fat liquefaction system Low-intensity laser fat liquefaction system Low-intensity laser fat liquefaction system Low-intensity laser fat liquefaction system Low-intensity laser fat liquefaction system Low-intensity laser fat liquefaction system Low-intensity laser fat liquefaction system Low-intensity laser fat liquefaction system Low-intensity laser fat liquefaction system Low-intensity laser fat liquefaction system Low-intensity laser fat liquefaction system Low-intensity laser fat liquefaction system Low-intensity laser fat liquefaction system Low-intensity laser fat liquefaction system Low-intensity laser fat liquefaction system
Primary Device ID07290016541632
NIH Device Record Key670feab4-666c-4e62-971b-51ea8e482808
Commercial Distribution StatusIn Commercial Distribution
Brand NameBLISS SYSTEM
Version Model NumberBL000001
Company DUNS533127663
Company NameVENUS CONCEPT 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016541281 [Primary]
GS107290016541632 [Package]
Contains: 07290016541281
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PKTLaser For Disruption Of Adipocyte Cells For Aesthetic Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-22
Device Publish Date2021-07-14

Devices Manufactured by VENUS CONCEPT LTD

07290016541632 - BLISS SYSTEM2021-07-22The Venus Bliss device is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the Venus Bliss device is intended for the treatment of the following medical conditions; using the MP2 applicator for delivery of RF energy combined with massage and magnetic field pulses: • Relief of minor muscle aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation • Temporary reduction in the appearance of cellulite
07290016541632 - BLISS SYSTEM2021-07-22 The Venus Bliss device is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with
07290016541564 - BODY LASER APPLICATOR SERVICE PACK, Bliss2021-07-22
07290016541618 - (MP)2 APPLICATOR BLISS2021-07-22
07290016541625 - BODY LASER APPLICATOR BLISS2021-07-22
07290016541717 - (MP)2 APPLICATOR SERVICE PACK, Bliss2021-07-22
07290016541724 - Belt Bliss2021-07-22
07290016541984 - Epileve Applicator Service Pack UDI Label2021-07-22 The Venus Epileve is intended for all Fitzpatrick skin types, including tanned skin, for use in dermatology, general and plastic
27290016541179 - HR 690XL Light Block package2020-05-01
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