FAQ 102

GUDID 07640260120051

FAQ™ 103 devices are over-the-counter home use devices intended for facial and neck skin stimulation, and non-invasive treatments of mild to moderate facial wrinkles for adult women with all skin tones.

Foreo AB

Radio-frequency skin contouring system

• Primary Device ID: 07640260120051
• NIH Device Record Key: f4796f48-6ebe-4241-b368-3907900e3e4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FAQ 102
• Version Model Number: Topaz
• 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	07640260120051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240616

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: 2024-07-26
• Device Publish Date: 2024-07-18

On-Brand Devices [FAQ 102]

• 07640260120112: FAQ™ 102 devices are over-the-counter home use devices intended for facial and neck skin stimu
• 07640260120051: FAQ™ 103 devices are over-the-counter home use devices intended for facial and neck skin stimu
• 07640260120044: FAQ™ 102 devices are over-the-counter home use devices intended for facial and neck skin stimu