Venus AIME

GUDID 00810060831250

Venus Concept Inc.

Multi-modality skin surface treatment system

• Primary Device ID: 00810060831250
• NIH Device Record Key: 0fc44104-3b0a-47aa-8cba-f8615210ec89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venus AIME
• Version Model Number: FP-60000
• 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	00810060831250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221011

FDA Product Code

• QAI: Powered Microneedle Device

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.

• 00810060831632 - ARTAS iX: 2024-07-12
• 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