BENIONE

GUDID 06975526410005

Shenzhen Noble Smart Manufacturing Tech. Co., Ltd.

Intense pulsed light skin surface treatment system

• Primary Device ID: 06975526410005
• NIH Device Record Key: 607ae2a3-f662-45fd-926a-324b91cd0869
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BENIONE
• Version Model Number: M052W1101
• Company DUNS: 550670270
• Company Name: Shenzhen Noble Smart Manufacturing Tech. 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975526410005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222598

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: 2023-01-18
• Device Publish Date: 2023-01-10