ESPADA 2 Plus

GUDID 07350120791764

ESPADA™ devices have been developed to be used as an at-home devices for the treatment of mild to moderate inflammatory acne on the facial area

Foreo AB

Blue-light phototherapy lamp, home-use

• Primary Device ID: 07350120791764
• NIH Device Record Key: 50bef319-8af3-40e3-bdcc-b9a1c41d6961
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESPADA 2 Plus
• Version Model Number: Pistachio
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	07350120791764 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162450

FDA Product Code

• OLP: Over-The-Counter Powered Light Based Laser For Acne

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: 2024-02-28
• Device Publish Date: 2024-02-20

On-Brand Devices [ESPADA 2 Plus]

• 07350120791764: ESPADA™ devices have been developed to be used as an at-home devices for the treatment of mild
• 07350120791757: ESPADA™ devices have been developed to be used as an at-home devices for the treatment of mild