ADVATx 684

GUDID 05700002052209

The laser system is for dermatological indications for use. The laser light is delivered to the patient through an applicator either a scanning hand p

Advalight ApS

Dermatological frequency-doubled solid-state laser system

• Primary Device ID: 05700002052209
• NIH Device Record Key: fa3c3b0e-01f7-4207-81cc-e8e9d3598d49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADVATx
• Version Model Number: 1.0
• Catalog Number: 684
• Company DUNS: 310762054
• Company Name: Advalight ApS
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4546965412
• Email: tma@advalight.com
• Phone: +4546965412
• Email: tma@advalight.com
• Phone: +4546965412
• Email: tma@advalight.com
• Phone: +4546965412
• Email: tma@advalight.com
• Phone: +4546965412
• Email: tma@advalight.com
• Phone: +4546965412
• Email: tma@advalight.com
• Phone: +4546965412
• Email: tma@advalight.com
• Phone: +4546965412
• Email: tma@advalight.com
• Phone: +4546965412
• Email: tma@advalight.com
• Phone: +4546965412
• Email: tma@advalight.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 150 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 150 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 150 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 150 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 150 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 150 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 150 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 150 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 150 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 150 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700002052209 [Primary]
GS1	05700002052216 [Package]; Package: colli [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132976

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-18