DioBreeze FS80020

GUDID 07290016681079

DioBreeze system supporting Laser applicators indicated for various treatments such as Hair Removal, Permanent Hair Reduction and pseudofolliculitis barbae (PFB)

FORMATK SYSTEMS LTD

Dermatological diode laser system

• Primary Device ID: 07290016681079
• NIH Device Record Key: 985f17e9-2654-48c6-9897-88fd5798306c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DioBreeze
• Version Model Number: FS80020
• Catalog Number: FS80020
• Company DUNS: 532396673
• Company Name: FORMATK SYSTEMS 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	07290016681079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162781

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: 2021-07-05
• Device Publish Date: 2021-06-25

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