HR 690XL Light Block package

GUDID 27290016541179

VENUS CONCEPT LTD

Multi-modality skin surface treatment system
Primary Device ID27290016541179
NIH Device Record Keyb2215d82-56b2-4678-830b-63f5f28dc998
Commercial Distribution StatusIn Commercial Distribution
Brand NameHR 690XL Light Block package
Version Model NumberPK000324
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS127290016541179 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-01
Device Publish Date2020-04-23

Devices Manufactured by VENUS CONCEPT LTD

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
27290016541179 - HR 690XL Light Block package2020-05-01

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