Cosmotology

GUDID 06970006971144

The LED Eve Mask (Model: EY-20R) is an Over-the-Counter (OTc) device intended for use in treating wrinkles within the periorbital region.

Shenzhen Kaiyan Medical Equipment Co,. Ltd

Blue/red/infrared phototherapy lamp

• Primary Device ID: 06970006971144
• NIH Device Record Key: efd31b7c-7511-4f22-ba39-697f375bc2a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cosmotology
• Version Model Number: EY-20R
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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	06970006971144 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233556

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: 2025-07-07
• Device Publish Date: 2025-06-28

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