Laser Engineering 1000-AUR

GUDID 00855045007510

Aurora MD30 Laser System

Laser Engineering, Inc.

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• Primary Device ID: 00855045007510
• NIH Device Record Key: 58c26797-e509-44dc-bbea-0c0f0616c651
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Laser Engineering
• Version Model Number: Aurora MD30
• Catalog Number: 1000-AUR
• Company DUNS: 787348452
• Company Name: Laser Engineering, Inc.
• 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: 6157395418
• Email: SALES@LASERENGINEERING.COM
• Phone: 6157395418
• Email: SALES@LASERENGINEERING.COM
• Phone: 6157395418
• Email: SALES@LASERENGINEERING.COM
• Phone: 6157395418
• Email: SALES@LASERENGINEERING.COM
• Phone: 6157395418
• Email: SALES@LASERENGINEERING.COM
• Phone: 6157395418
• Email: SALES@LASERENGINEERING.COM
• Phone: 6157395418
• Email: SALES@LASERENGINEERING.COM
• Phone: 6157395418
• Email: SALES@LASERENGINEERING.COM
• Phone: 6157395418
• Email: SALES@LASERENGINEERING.COM
• Phone: 6157395418
• Email: SALES@LASERENGINEERING.COM
• Phone: 6157395418
• Email: SALES@LASERENGINEERING.COM
• Phone: 6157395418
• Email: SALES@LASERENGINEERING.COM
• Phone: 6157395418
• Email: SALES@LASERENGINEERING.COM
• Phone: 6157395418
• Email: SALES@LASERENGINEERING.COM
• Phone: 6157395418
• Email: SALES@LASERENGINEERING.COM
• Phone: 6157395418
• Email: SALES@LASERENGINEERING.COM
• Phone: 6157395418
• Email: SALES@LASERENGINEERING.COM
• Phone: 6157395418
• Email: SALES@LASERENGINEERING.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855045007510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211605

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: 2023-10-24
• Device Publish Date: 2023-10-16

On-Brand Devices [Laser Engineering]

• 00855045007510: Aurora MD30 Laser System
• 00855045007114: 125mm Handpiece for CO2 Laser System