Venus Legacy (120V)

GUDID 00810060830833

Venus Concept Inc.

Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system

• Primary Device ID: 00810060830833
• NIH Device Record Key: ac26cdfa-ac7f-4ad9-9771-b97f14e5c276
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venus Legacy (120V)
• Version Model Number: LE120004
• Company DUNS: 117333774
• Company Name: Venus Concept Inc.
• 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: true
• 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	00810060830833 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-16
• Device Publish Date: 2023-06-08

Devices Manufactured by Venus Concept Inc.

• 00810060830079 - ARTAS System: 2023-06-16
• 00810060830444 - Venus Bliss: 2023-06-16
• 00810060830574 - Venus Velocity: 2023-06-16
• 00810060830628 - Venus Viva: 2023-06-16
• 00810060830680 - Venus Versa: 2023-06-16
• 00810060830826 - Venus Legacy (100V): 2023-06-16
• 00810060830833 - Venus Legacy (120V): 2023-06-16
• 00810060830833 - Venus Legacy (120V): 2023-06-16
• 00810060830840 - Venus Legacy (240V): 2023-06-16