Me HU-FG01271

GUDID 20806248006118

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 Red/blue light phototherapy unit

• Primary Device ID: 20806248006118
• NIH Device Record Key: 0489eb83-4174-4f7b-b84b-631022ec31df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Me
• Version Model Number: Series 14
• Catalog Number: HU-FG01271
• 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	00806248006114 [Primary]
GS1	10806248006111 [Package]; Contains: 00806248006114; Package: Inner carton [3 Units]; In Commercial Distribution
GS1	20806248006118 [Package]; Contains: 10806248006111; 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: 2016-09-24

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