CoolBreeze

GUDID 00818257020074

Cool Breeze LED Wand - Red

GENESIS BIOSYSTEMS, INC.

Cosmetic red-light phototherapy system, home-use

• Primary Device ID: 00818257020074
• NIH Device Record Key: f42bda07-5b8b-40d6-8c4b-c81af106d162
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoolBreeze
• Version Model Number: D11-0318-503
• Company DUNS: 067933700
• Company Name: GENESIS BIOSYSTEMS, INC.
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 972-315-7888
• Email: customerservice@genesisbiosystems.com
• Phone: 972-315-7888
• Email: customerservice@genesisbiosystems.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818257020074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131142

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: 2020-02-24
• Device Publish Date: 2017-04-21

On-Brand Devices [CoolBreeze]

• 00818257020081: Cool Breeze LED wand - Blue
• 00818257020074: Cool Breeze LED Wand - Red