FAQ 201

GUDID 07640260120167

FAQ™ 201 is intended to use LED light for the treatment of wrinkles and mild to moderate acne.

Foreo AB

Blue/red/infrared phototherapy lamp

• Primary Device ID: 07640260120167
• NIH Device Record Key: e56adebd-b216-4664-87a9-3df21119c1e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FAQ 201
• Version Model Number: Pink Ruby
• 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	07640260120167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240378

FDA Product Code

• OHS: Light Based Over The Counter Wrinkle Reduction

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: 2024-05-02
• Device Publish Date: 2024-04-24

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