XEMIS

GUDID 06977593370114

Xemis Medical Technology (shenzhen) Co, LTD

Cosmetic red-light phototherapy system, professional

• Primary Device ID: 06977593370114
• NIH Device Record Key: 6a4a1da2-8596-4391-9fc1-2d649045975d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XEMIS
• Version Model Number: BL-10
• Company DUNS: 847284864
• Company Name: Xemis Medical Technology (shenzhen) Co, LTD
• Device Count: 1
• DM Exempt: true
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06977593370114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243993

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2025-04-11
• Device Publish Date: 2025-04-03