Vellus

GUDID 06974223650103

Vellus LED Therapy device

Shenzhen Leaflife Technology Co., Ltd.

Dermatological diode laser system

• Primary Device ID: 06974223650103
• NIH Device Record Key: 3f6621c8-0c5a-4064-b2af-1f59b003327d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vellus
• Version Model Number: HYPER HR
• Company DUNS: 419291256
• Company Name: Shenzhen Leaflife Technology Co., 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	06974223650103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220103

FDA Product Code

• OHT: Light Based Over-The-Counter Hair Removal

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: 2023-03-20
• Device Publish Date: 2023-03-10

Devices Manufactured by Shenzhen Leaflife Technology Co., Ltd.

• 06974223650042 - Planar LED mate: 2024-09-17
• 06974223650073 - Mjolnir Pro.: 2024-09-17
• 06974223650103 - Vellus: 2023-03-20Vellus LED Therapy device
• 06974223650103 - Vellus: 2023-03-20 Vellus LED Therapy device
• 06974223650004 - Leaf life: 2022-11-14
• 06974223650028 - Leaf life: 2022-11-11
• 06974223650011 - Leaf life: 2021-06-11