Me HU-FG01871

GUDID 20806248007559

Home use, hand held, rechargeable 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: 20806248007559
• NIH Device Record Key: 6a61643c-ca83-4e36-a1eb-ff08541763e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Me
• Version Model Number: Series 14
• Catalog Number: HU-FG01871
• 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	00806248007555 [Primary]
GS1	10806248007552 [Package]; Contains: 00806248007555; Package: Inner Carton [6 Units]; In Commercial Distribution
GS1	20806248007559 [Package]; Contains: 10806248007552; Package: Master Carton [4 Units]; In Commercial Distribution

FDA Product Code

• OLP: Over-The-Counter Powered Light Based Laser For Acne

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-08-23

On-Brand Devices [Me]

• 00806248007562: Home use, hand held, rechargeable red light (660nm ) LED emitting device that is used for the tr
• 20806248007559: Home use, hand held, rechargeable blue light (414nm ) LED emitting device that is used for the t
• 00806248007463: Home use, hand held, rechargeable red light (660nm ) LED emitting device that is used for the tr
• 00806248007432: Home use, hand held, rechargeable blue light (414nm ) LED emitting device that is used for the t
• 00806248007425: Home use, hand held, rechargeable red light (660nm ) LED emitting device that is used for the tr
• 00806248007289: Home use, hand held, rechargeable blue light (414nm ) LED emitting device that is used for the t
• 00806248007241: Home use, hand held, rechargeable blue light (414nm ) LED emitting device that is used for the t
• 00806248006459: Home use, hand held, rechargeable red light (660nm ) LED emitting device that is used for the tr
• 20806248006118: Home use, hand held, rechargeable blue light (414nm ) LED emitting device that is used for the t