DermRays Revive

GUDID 06940481500139

Wuhan Lotuxs Technology Co.,Ltd.

Dermatological diode laser system

• Primary Device ID: 06940481500139
• NIH Device Record Key: 39f90306-0fc1-46e8-af7e-74229c050e5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DermRays Revive
• Version Model Number: LHR-S5-1064
• Company DUNS: 421343727
• Company Name: Wuhan Lotuxs Technology 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: true
• 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	06940481500139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231910

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: 2024-09-06
• Device Publish Date: 2024-08-29

Devices Manufactured by Wuhan Lotuxs Technology Co.,Ltd.

• 06940481500139 - DermRays Revive: 2024-09-06
• 06940481500139 - DermRays Revive: 2024-09-06
• 06940481500207 - Diode Laser Hair Removal: 2024-09-06
• 06940481500221 - Diode Laser Hair Removal: 2024-09-06
• 06940481500061 - Diode Laser Hair Removal: 2024-09-04
• 06940481500078 - Diode Laser Hair Removal: 2024-09-04
• 06940481500085 - Diode Laser Hair Removal: 2024-09-04
• 06940481500047 - Diode Laser Hair Removal: 2024-09-02