CO2 Laser Therapy Machine

GUDID 06970453270104

Beijing ADSS Development Co., Ltd.

Dermatological carbon dioxide laser system

• Primary Device ID: 06970453270104
• NIH Device Record Key: f681051e-1230-48ce-ba4d-d03d9c2044ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CO2 Laser Therapy Machine
• Version Model Number: FG 900
• Company DUNS: 529128739
• Company Name: Beijing ADSS Development Co., Ltd.
• 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: true
• Donation Id Number: false
• 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	06970453270104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161925

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: 2022-09-07
• Device Publish Date: 2022-08-30

On-Brand Devices [CO2 Laser Therapy Machine]

• 06970453270128: FG 900-C
• 06970453270111: FG 900-B
• 06970453270104: FG 900