SLT

GUDID 06971858360162

Jiangxi Medex Technology Co., Ltd.

General/multiple surgical diode laser system

• Primary Device ID: 06971858360162
• NIH Device Record Key: ba81b06d-0c26-40a6-8112-92d88c0901ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SLT
• Version Model Number: SACSll
• 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	06971858360162 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952754

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: 2023-11-20
• Device Publish Date: 2023-11-10

Devices Manufactured by Jiangxi Medex Technology Co., Ltd.

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