tamburo Thulium Fiber Laser System

GUDID 06974994310350

The Tamburo Thulium Fiber Laser System is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy gastroenterological surgery and gynecological surgery.

menovex Medical Technology (Shenzhen) Co., Ltd

General/multiple surgical solid-state laser system

• Primary Device ID: 06974994310350
• NIH Device Record Key: 51465baa-a1c3-4860-b194-d0a568cf6bfc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: tamburo Thulium Fiber Laser System
• Version Model Number: MIL-TFL-600A
• Company DUNS: 709445289
• Company Name: menovex Medical Technology (Shenzhen) 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: 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	06974994310350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251303

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: 2025-12-19
• Device Publish Date: 2025-12-11

On-Brand Devices [tamburo Thulium Fiber Laser System]

• 06974994310404: The Tamburo Thulium Fiber Laser System is intended for incision, excision, resection, ablation,
• 06974994310398: The Tamburo Thulium Fiber Laser System is intended for incision, excision, resection, ablation,
• 06974994310350: The Tamburo Thulium Fiber Laser System is intended for incision, excision, resection, ablation,