MultiPulse TFL J19-8100-000

GUDID 04058784002693

The MultiPulse TFL is a surgical laser with a treatment beam with a wavelength of 1940nm generated by a diode pumped thulium fiber laser (TFL) and is used in Urology and general surgery. Nominal Rating for this model: 100-120V

Asclepion Laser Technologies GmbH

General/multiple surgical solid-state laser system

• Primary Device ID: 04058784002693
• NIH Device Record Key: f453ec1c-01fd-4a12-a8fa-8aef45f7af16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MultiPulse TFL
• Version Model Number: J19-8100-000
• Catalog Number: J19-8100-000
• Company DUNS: 332247852
• Company Name: Asclepion Laser Technologies GmbH
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4936417700401
• Email: service@asclepion.com
• Phone: +4936417700401
• Email: service@asclepion.com
• Phone: +4936417700401
• Email: service@asclepion.com
• Phone: +4936417700401
• Email: service@asclepion.com
• Phone: +4936417700401
• Email: service@asclepion.com
• Phone: +4936417700401
• Email: service@asclepion.com
• Phone: +4936417700401
• Email: service@asclepion.com
• Phone: +4936417700401
• Email: service@asclepion.com
• Phone: +4936417700401
• Email: service@asclepion.com
• Phone: +4936417700401
• Email: service@asclepion.com
• Phone: +4936417700401
• Email: service@asclepion.com
• Phone: +4936417700401
• Email: service@asclepion.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04058784002693 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241600

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: 2025-12-05
• Device Publish Date: 2025-11-27

On-Brand Devices [MultiPulse TFL]

• 04058784002693: The MultiPulse TFL is a surgical laser with a treatment beam with a wavelength of 1940nm generat
• 04058784002655: The MultiPulse TFL is a surgical laser with a treatment beam with a wavelength of 1940nm generat