Thermal Therapy System Instructions for Use

GUDID 17340007000390

Clinical Laserthermia Systems AB

General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system

• Primary Device ID: 17340007000390
• NIH Device Record Key: 2b104238-ec68-4ff4-9d88-f9eb6284ccc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermal Therapy System Instructions for Use
• Version Model Number: L-2016-051EN
• Company DUNS: 774856749
• Company Name: Clinical Laserthermia Systems AB
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• 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	17340007000390 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142216

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-18

Devices Manufactured by Clinical Laserthermia Systems AB

• 17340007000611 - Mobile Laser Unit: 2022-11-07
• 37340007000653 - Tissue Temp Probe: 2022-11-07
• 37340007000660 - Tissue Temp Probe: 2022-11-07
• 37340007000677 - Tissue Temp Probe: 2022-11-07
• 37340007000684 - Tissue Temp Probe: 2022-11-07
• 37340007000691 - Tissue Temp Probe: 2022-11-07
• 37340007000707 - Tissue Temp Probe: 2022-11-07
• 37340007000714 - Tissue Temp Probe: 2022-11-07