Qure

GUDID 08719327598719

The Q-Rejuvalight Pro Facewear (Model: P19-0023) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.

Shenzhen Kaiyan Medical Equipment Co,. Ltd

Cosmetic red-light phototherapy system, home-use

• Primary Device ID: 08719327598719
• NIH Device Record Key: 6d0985c3-833a-4d5c-ad11-6b25871e412d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Qure
• Version Model Number: P19-0023
• Company DUNS: 543062382
• Company Name: Shenzhen Kaiyan Medical Equipment Co,. Ltd
• 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: 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	08719327598719 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230042

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: 2024-02-07
• Device Publish Date: 2024-01-30

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