LaserPro

GUDID 06971858363927

Jiangxi Medex Technology Co., Ltd.

General/multiple surgical diode laser system

• Primary Device ID: 06971858363927
• NIH Device Record Key: 97d4e0cc-e6fe-45f3-9a7d-5d85dc07729c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LaserPro
• Version Model Number: LaserPro 980
• Company DUNS: 544457636
• Company Name: Jiangxi Medex 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971858363927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082721

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: 2022-11-25
• Device Publish Date: 2022-11-17

Devices Manufactured by Jiangxi Medex Technology Co., Ltd.

• 06971858360162 - SLT: 2023-11-20
• 06971858363927 - LaserPro: 2022-11-25
• 06971858363927 - LaserPro: 2022-11-25