Echo PDMS00257

GUDID 08059173396375

QUANTA SYSTEM SPA

Dermatological diode laser system

• Primary Device ID: 08059173396375
• NIH Device Record Key: 6201b532-1779-46e9-9a1c-b6305eda35f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Echo
• Version Model Number: Echo
• Catalog Number: PDMS00257
• 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	08059173396375 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232236

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: 2024-07-01
• Device Publish Date: 2024-06-21

Devices Manufactured by QUANTA SYSTEM SPA

• 08059173396375 - Echo: 2024-07-01
• 08059173396375 - Echo: 2024-07-01
• 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