Tanda HU-FG00631

GUDID 20806248004930

Home use, hand held, blue light (414nm ) LED emitting device that is used for the treatment of mild to moderate inflammatory acne.

Tanda Beauty Canada, Inc

Red/blue light phototherapy unit

• Primary Device ID: 20806248004930
• NIH Device Record Key: 3bb35aae-5282-4361-b206-bb8fb8add657
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tanda
• Version Model Number: Series 4
• Catalog Number: HU-FG00631
• Company DUNS: 248047115
• Company Name: Tanda Beauty Canada, 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00806248004936 [Primary]
GS1	10806248004933 [Package]; Contains: 00806248004936; Package: Inner Carton [3 Units]; In Commercial Distribution
GS1	20806248004930 [Package]; Contains: 10806248004933; Package: Master Carton [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080591

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-02

On-Brand Devices [Tanda]

• 20806248005180: Home use, hand held, blue light (414nm ) LED emitting device that is used for the treatment of m
• 20806248004930: Home use, hand held, blue light (414nm ) LED emitting device that is used for the treatment of m
• 00806248004929: Home use, hand held, blue light (414nm ) LED emitting device that is used for the treatment of m