ADSS

GUDID 06970453270005

Beijing ADSS Development Co., Ltd.

Intense pulsed light skin surface treatment system

• Primary Device ID: 06970453270005
• NIH Device Record Key: 87a80eee-621e-4b2d-a3d3-de4d0a5f3420
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADSS
• Version Model Number: VE2000
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970453270005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161286
• Premarket Notification: K192295

FDA Product Code

• OLP: Over-The-Counter Powered Light Based Laser For Acne
• ONF: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-09

On-Brand Devices [ADSS]

• 06970453270005: VE2000
• 06970453270043: VE2000