Epileve Applicator Service Pack UDI Label

GUDID 07290016541984

The Venus Epileve is intended for all Fitzpatrick skin types, including tanned skin, for use in dermatology, general and plastic surgery applications for: • Hair removal; • Permanent hair reduction (defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen); and • Treatment of pseudofolliculitis barbae.

VENUS CONCEPT LTD

Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system
Primary Device ID07290016541984
NIH Device Record Key12de2d6a-9bf9-448e-b713-9573e4c7448d
Commercial Distribution StatusIn Commercial Distribution
Brand NameEpileve Applicator Service Pack UDI Label
Version Model NumberSPK230010
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
GS107290016541984 [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 Date2021-07-22
Device Publish Date2021-07-14

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 Label2021-07-22The Venus Epileve is intended for all Fitzpatrick skin types, including tanned skin, for use in dermatology, general and plastic surgery applications for: • Hair removal; • Permanent hair reduction (defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen); and • Treatment of pseudofolliculitis barbae.
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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