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

• Primary Device ID: 07290016541984
• NIH Device Record Key: 12de2d6a-9bf9-448e-b713-9573e4c7448d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epileve Applicator Service Pack UDI Label
• Version Model Number: SPK230010
• Company DUNS: 533127663
• Company Name: VENUS CONCEPT LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016541984 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200786

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-22
• Device Publish Date: 2021-07-14

Devices Manufactured by VENUS CONCEPT LTD

• 07290016541632 - BLISS SYSTEM: 2021-07-22 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, Bliss: 2021-07-22
• 07290016541618 - (MP)2 APPLICATOR BLISS: 2021-07-22
• 07290016541625 - BODY LASER APPLICATOR BLISS: 2021-07-22
• 07290016541717 - (MP)2 APPLICATOR SERVICE PACK, Bliss: 2021-07-22
• 07290016541724 - Belt Bliss: 2021-07-22
• 07290016541984 - Epileve Applicator Service Pack UDI Label: 2021-07-22The 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 Label: 2021-07-22 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 package: 2020-05-01