KES

GUDID 06971513121015

Beijing KES Biology Technology Co.,Ltd.

Intense pulsed light skin surface treatment system

• Primary Device ID: 06971513121015
• NIH Device Record Key: b767a642-9885-42ed-bbc0-0acb869c7b60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KES
• Version Model Number: MED-210
• Company DUNS: 525608013
• Company Name: Beijing KES Biology Technology 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: false
• 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	06971513121015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122995

FDA Product Code

• 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: 1
• Public Version Date: 2021-04-02
• Device Publish Date: 2021-03-25

On-Brand Devices [KES]

• 06971513121022: MED-230
• 06971513121039: MED-810A
• 06971513121015: MED-210
• 06971513121046: MED-808