AuraLux

GUDID 00850039149054

Fractional Mid IR Fiber Laser System

Acclaro Corporation

Dermatological solid-state laser system

• Primary Device ID: 00850039149054
• NIH Device Record Key: f9b05b55-a1d1-406b-8c66-ae54b6d813b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AuraLux
• Version Model Number: AS-AL-20000
• Company DUNS: 105941754
• Company Name: Acclaro Corporation
• 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: 1.866.222.5276
• Email: customerservice@acclaromd.com
• Phone: 1.866.222.5276
• Email: customerservice@acclaromd.com
• Phone: 1.866.222.5276
• Email: customerservice@acclaromd.com
• Phone: 1.866.222.5276
• Email: customerservice@acclaromd.com
• Phone: 1.866.222.5276
• Email: customerservice@acclaromd.com
• Phone: 1.866.222.5276
• Email: customerservice@acclaromd.com
• Phone: 1.866.222.5276
• Email: customerservice@acclaromd.com
• Phone: 1.866.222.5276
• Email: customerservice@acclaromd.com
• Phone: 1.866.222.5276
• Email: customerservice@acclaromd.com
• Phone: 1.866.222.5276
• Email: customerservice@acclaromd.com
• Phone: 1.866.222.5276
• Email: customerservice@acclaromd.com
• Phone: 1.866.222.5276
• Email: customerservice@acclaromd.com
• Phone: 1.866.222.5276
• Email: customerservice@acclaromd.com
• Phone: 1.866.222.5276
• Email: customerservice@acclaromd.com
• Phone: 1.866.222.5276
• Email: customerservice@acclaromd.com
• Phone: 1.866.222.5276
• Email: customerservice@acclaromd.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850039149054 [Primary]

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: 2025-04-09
• Device Publish Date: 2025-04-01

On-Brand Devices [AuraLux]

• 00850039149054: Fractional Mid IR Fiber Laser System
• 10850039149075: AuraLux Disposable Tip Kit
• 00850039149085: AuraLux Fractional Mid IR Fiber Laser System
• 00850039149078: AuraLux Disposable Tip