Laserlith I-dust

GUDID 08033945936938

Manufactured for Edap TMS

QUANTA SYSTEM SPA

General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system

• Primary Device ID: 08033945936938
• NIH Device Record Key: 3c6c6077-d8f4-4be6-baff-0a45be25091a
• Commercial Distribution Discontinuation: 2024-05-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Laserlith I-dust
• Version Model Number: PVMS00042
• Company DUNS: 436045833
• Company Name: QUANTA SYSTEM 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033945936938 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141403

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: 2024-05-23
• Device Publish Date: 2017-05-04

Devices Manufactured by QUANTA SYSTEM SPA

• 08033945936938 - Laserlith I-dust: 2024-05-23Manufactured for Edap TMS
• 08033945936938 - Laserlith I-dust: 2024-05-23 Manufactured for Edap TMS
• 08059173396474 - Karma: 2023-12-21
• 08059173396399 - Rosso: 2023-06-23
• 08059173396405 - Rosso: 2023-06-23
• 08033945934767 - Quantabella: 2023-06-16
• 08033945937492 - Litho 60: 2023-06-16
• 08033945938369 - Litho 100: 2023-06-16
• 08059173395491 - Optical Fiber Reusable 10x: 2023-06-02 Reusable 10x optical fiber with 200 um diameter