iRestore

Basic Information

• Brand Name: iRestore
• Primary DI: 00859690003897
• Version / Model: ID-500
• Company Name: Remax Medi-Tech (Shenzhen) Corporation
• Labeler DUNS: 544382003
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-21
• Public Version: 2
• Public Version Date: 2022-12-12
• Public Version Status: Update
• Public Device Record Key: 4eccc7eb-5aa2-4847-8a46-da0410b7c5ef

Device Description

iRestore Hair Growth System, ID-500, is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have Norwood Hamilton Classifications of Ila to V and in females who have Ludgwig-Savin Classifications of I to II . All users should also have Fitzpatrick Skin Types I to IV. The iRestore Hair Growth System uses 51 low-level lasers and 69 light-emitting diodes .

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OAP	Laser, Comb, Hair	Physical Medicine	890.5500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47417	Hair growth laser device	An electronic, portable, head-worn or hand-operated device intended to be operated by a layperson affected by scalp hair loss (i.e., receding hairline/baldness due to androgenic alopecia) to stimulate hair growth on the scalp through the application of scheduled low-level laser therapy (LLLT). The device uses individual laser diodes to direct laser light at the scalp and may include features (e.g., a comb) to separate the user's hair to allow for improved penetration of the laser light. It is intended for use in the home or a clinical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859690003897	GS1
Package	10859690003894	GS1		4	In Commercial Distribution