iRestore

GUDID 10859690003672

The iRestore Professional 282 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 I-II, and in both with Fitzpatrick Skin Phototypes I-IV.

FREEDOM LASER THERAPY, INC.

Hair growth laser device

• Primary Device ID: 10859690003672
• NIH Device Record Key: e9d200bd-840f-4f4f-9c59-19252be9acfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iRestore
• Version Model Number: ID-505
• Company DUNS: 026237853
• Company Name: FREEDOM LASER THERAPY, 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: true
• Lot Batch: false
• 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	00859690003675 [Primary]
GS1	10859690003672 [Package]; Contains: 00859690003675; 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: 2019-07-17
• Device Publish Date: 2019-07-09