Venus Legacy kit

GUDID 07290016540055

Venus Legacy system and applicators

VENUS CONCEPT LTD

Radio-frequency skin contouring system

• Primary Device ID: 07290016540055
• NIH Device Record Key: 7e772522-92cb-4cb1-89ac-3ec30dbfac16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venus Legacy kit
• Version Model Number: PK000008
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• 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	07290016540055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143554

FDA Product Code

• PBX: Massager, Vacuum, Radio Frequency Induced Heat

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Venus Legacy kit]

• 07290016540116: Venus Legacy system and applicators
• 07290016540055: Venus Legacy system and applicators