E-LIGHT LINE LAMP570AC

GUDID 08056389700712

ESPANSIONE MARKETING SPA

Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system

• Primary Device ID: 08056389700712
• NIH Device Record Key: de60efd1-4cbc-47f3-acde-b10e4cb4a129
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E-LIGHT LINE
• Version Model Number: LAMP570AC
• Catalog Number: LAMP570AC
• Company DUNS: 339474539
• Company Name: ESPANSIONE MARKETING 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	08056389700712 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092734

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: 2022-07-26
• Device Publish Date: 2022-07-18

On-Brand Devices [E-LIGHT LINE]

• 08056389700217: LED MASK/BLUE-05
• 08056389700422: LED MASK H/YELLOW
• 08056389700415: LED MASK H/BLUE
• 08056389700453: LED MASK H-20/BLUE
• 08056389700446: LED MASK H-05/BLUE
• 08056389700712: LAMP570AC
• 08056389701412: LED MASK H-05/YELLOW
• 08056389701375: MASK LM YELLOW/CE-0500
• 08056389701368: MASK LM BLUE/CE-0500
• 08056389701351: MASK LM RED/CE-0500
• 08056389701047: EPI-C PLUS
• 08056389701030: IPL LAMP-DS
• 08056389701023: IPL LAMP-LS
• 08056389701016: IPL LAMP-550
• 08056389701009: IPL LAMP-390