DemarkQ

GUDID 08720299044227

The DemarkQ is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.

Light Tree Ventures Europe B.V.

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• Primary Device ID: 08720299044227
• NIH Device Record Key: 3eb2d520-cd76-4dfb-a50a-e0eaa144ad10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DemarkQ
• Version Model Number: P19-0007
• Company DUNS: 493246808
• Company Name: Light Tree Ventures Europe B.V.
• 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: true
• 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	08720299044227 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203214

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: 2022-04-11
• Device Publish Date: 2022-04-01