ATL

GUDID 06970507240107

Advanced Technology Laser Co.,Ltd.

Dermatological carbon dioxide laser system

• Primary Device ID: 06970507240107
• NIH Device Record Key: ce300959-1437-423c-8081-d5e3d719117a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATL
• Version Model Number: ATL-150
• Company DUNS: 547070719
• Company Name: Advanced Technology Laser Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970507240107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083918

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: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-10-26

On-Brand Devices [ATL]

• 06970507240213: SoomthTouch
• 06970507240206: GlobalCure-SC6
• 06970507240121: eBeam
• 06970507240114: ATL-250
• 06970507240107: ATL-150
• 06970507240022: Angelite-DDC
• 06970507240015: Angelite-SDC