Laser Applicator Non-cooled Instructions for Use

GUDID 17340007000529

Clinical Laserthermia Systems AB

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 17340007000529
• NIH Device Record Key: 8b3d075b-a6ab-41a6-bf01-6bb80830472c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Laser Applicator Non-cooled Instructions for Use
• Version Model Number: L-2016-055
• 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: true
• 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	17340007000529 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163103

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-07-10

On-Brand Devices [Laser Applicator Non-cooled Instructions for Use]

• 17340007000529: L-2016-055
• 17340007000505: L-2015-049