iRestore

GUDID 00859690003361

The iRestore Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I – II, males who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

Remax medi-tech(Shenzhen)Corporation

Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device

• Primary Device ID: 00859690003361
• NIH Device Record Key: 4d8c86bb-3958-4f92-8c49-a4a481aa1412
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iRestore
• Version Model Number: ID-500
• Company DUNS: 544382003
• Company Name: Remax medi-tech(Shenzhen)Corporation
• 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: true
• Lot Batch: true
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859690003361 [Primary]
GS1	10859690003368 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151662

FDA Product Code

• OAP: Laser, Comb, Hair

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: 2018-09-12
• Device Publish Date: 2016-09-23