Diode Laser Therapy Machine

GUDID 06970453270067

Beijing ADSS Development Co., Ltd.

Dermatological diode laser system

• Primary Device ID: 06970453270067
• NIH Device Record Key: 1b404199-f69c-4280-80db-85badcf8a3f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diode Laser Therapy Machine
• Version Model Number: FG 2000
• 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	06970453270067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161692

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 [Diode Laser Therapy Machine]

• 06970453270098: FG 2000-D
• 06970453270081: FG 2000-C
• 06970453270074: FG 2000-B
• 06970453270067: FG 2000