MLAY

GUDID 06970275250094

Shenzhen Mareal Tech Co.,Ltd

Cosmetic red-light phototherapy system, home-use

• Primary Device ID: 06970275250094
• NIH Device Record Key: 0cada9d0-2434-47a3-89ce-7bae759d1ce2
• Commercial Distribution Discontinuation: 2020-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MLAY
• Version Model Number: T2
• Company DUNS: 544426063
• Company Name: Shenzhen Mareal Tech Co.,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: 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	06970275250094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172883

FDA Product Code

• OHT: Light Based Over-The-Counter Hair Removal

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: 2018-05-15

On-Brand Devices [MLAY]

• 06970275250100: T3
• 06970275250094: T2
• 06970275250087: T1