LASER THERMAL THERAPY KIT S E

GUDID 08052286590500

One box containing 20 fibers (Fiber Optic for PLA S) and 20 needles (S)

ELESTA SPA

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

• Primary Device ID: 08052286590500
• NIH Device Record Key: 689293d8-05ab-4187-960d-62cf1397e535
• 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: false
• 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	08052286590500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K260632

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: 2026-04-01
• Device Publish Date: 2026-03-24

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)