iRestore

GUDID 10859690003917

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

Remax Medi-Tech (Shenzhen) Corporation

Hair growth laser device

• Primary Device ID: 10859690003917
• NIH Device Record Key: 8b349a97-e631-4cb9-92c6-ea51ab49b1cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iRestore
• Version Model Number: ID-510
• 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: false
• 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	00859690003910 [Primary]
GS1	10859690003917 [Package]; Contains: 00859690003910; Package: [4 Units]; In Commercial Distribution

FDA Product Code

• OAP: Laser, Comb, Hair

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-09
• Device Publish Date: 2023-08-01

On-Brand Devices [iRestore]

• 00859690003897: iRestore Hair Growth System, ID-500, is indicated to treat androgenetic alopecia for men and wom
• 10859690003917: The iRestore Elite is indicated to promote hair growth in males who have Norwood-Hamilton Classi