ESPADA Acne-Clearing Blue Light Pen

GUDID 07350092130011

The ESPADA Acne-Clearing Blue Light Pen is intended for use as an at-home device for the treatment of mild to moderate inflammatory acne.

Foreo AB

Blue-light phototherapy lamp, home-use

• Primary Device ID: 07350092130011
• NIH Device Record Key: 9467958a-c2fb-412a-86a5-467741314ccb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESPADA Acne-Clearing Blue Light Pen
• Version Model Number: ESPADA Pink
• 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	07350092130011 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-01-09

On-Brand Devices [ESPADA Acne-Clearing Blue Light Pen]

• 07350092130288: The ESPADA Acne-Clearing Blue Light Pen is intended for use as an at-home device for the treatme
• 07350092130271: The ESPADA Acne-Clearing Blue Light Pen is intended for use as an at-home device for the treatme
• 07350092130011: The ESPADA Acne-Clearing Blue Light Pen is intended for use as an at-home device for the treatme