Luna 4 Plus

GUDID 07350120791238

Luna 4 plus is a Near-Infrared Heated Cleansing Device With Red LED light & Microcurrent Massage Microcurrent: indicated for facial stimulation RED+IR: indicated for treat periorbital wrinkle

Foreo AB

Blue/red/infrared phototherapy lamp

• Primary Device ID: 07350120791238
• NIH Device Record Key: a36a9f69-680c-45fd-a7e2-f2973f3fb895
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luna 4 Plus
• Version Model Number: Lavender
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350120791238 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241102

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: 2024-10-04
• Device Publish Date: 2024-09-26

On-Brand Devices [Luna 4 Plus]

• 07350120791245: Luna 4 plus is a Near-Infrared Heated Cleansing Device With Red LED light & Microcurrent Massage
• 07350120791238: Luna 4 plus is a Near-Infrared Heated Cleansing Device With Red LED light & Microcurrent Massage