BEAR 2 eyes & lips

GUDID 07350120791740

Bear 2 eyes & lips is intended for facial and neck stimulation, and are indicated for over-the-counter cosmetic use.

Foreo AB

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 07350120791740
• NIH Device Record Key: b9882351-1d8a-47e2-8d0c-012adc1624f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEAR 2 eyes & lips
• Version Model Number: Arctic Blue
• Company DUNS: 352394143
• Company Name: Foreo AB
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350120791740 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200803

FDA Product Code

• NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes

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: 2024-03-15
• Device Publish Date: 2024-03-07

On-Brand Devices [BEAR 2 eyes & lips]

• 07350120791740: Bear 2 eyes & lips is intended for facial and neck stimulation, and are indicated for over-the-c
• 07350120791733: Bear 2 eyes & lips is intended for facial and neck stimulation and are indicated for over-the-co