Laser Thermal Therapy Kit S E

GUDID 08052286590210

The LASER THERMAL THERAPY KIT is used to transfer laser energy from the laser unit to the tissue site for the treatment. The LASER THERMAL THERAPY KIT consist of a Fiber Optic for PLA (272micron core quartz-quartz fiber with distal end outer diameter 420micron and NA 0.2) and an introducer needle (21G). The device is sterile and single use.

ELESTA SPA

General/multiple surgical laser system beam guide, single-use

• Primary Device ID: 08052286590210
• NIH Device Record Key: e3d55835-3bc0-4ccb-a393-94e0fe8dfb96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Laser Thermal Therapy Kit S E
• Version Model Number: EI KT0 0011 001
• Company DUNS: 895683282
• Company Name: ELESTA SPA
• 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: true
• Lot Batch: true
• Serial Number: false
• 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	08052286590210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230460

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-14
• Device Publish Date: 2023-11-06

On-Brand Devices [Laser Thermal Therapy Kit S E]

• 08052286590210: The LASER THERMAL THERAPY KIT is used to transfer laser energy from the laser unit to the tissue
• 08052286590500: One box containing 20 fibers (Fiber Optic for PLA S) and 20 needles (S)