Medical Thulium Fiber Laser Systems

GUDID 06976812430158

Rhein Laser Technologies Co.,Ltd.

Laser lithotripsy system

• Primary Device ID: 06976812430158
• NIH Device Record Key: 8061f7c4-4705-4a00-91ec-c2ab48c591c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medical Thulium Fiber Laser Systems
• Version Model Number: UroFiber 60Q
• Company DUNS: 704587822
• Company Name: Rhein Laser Technologies 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	06976812430158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242293

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: 2025-01-15
• Device Publish Date: 2025-01-07

Devices Manufactured by Rhein Laser Technologies Co.,Ltd.

• 06976812430202 - Smart Laser Therapy System: 2026-01-27
• 06976812430158 - Medical Thulium Fiber Laser Systems: 2025-01-15
• 06976812430158 - Medical Thulium Fiber Laser Systems: 2025-01-15
• 06976812430127 - Artemis Diode Laser System: 2024-09-23
• 06976812430134 - Artemis Diode Laser System: 2024-09-23
• 06976812430141 - Artemis Diode Laser System: 2024-09-23
• 06976812430110 - TitanPico Laser Workstation: 2024-09-20