Irradiation Aesthetic Device

Basic Information

• Brand Name: Irradiation Aesthetic Device
• Primary DI: 06971777450029
• Version / Model: HairPro
• Company Name: Chongqing Peninsula Medical Technology Co., Ltd.
• Labeler DUNS: 545832254
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-18
• Public Version: 2
• Public Version Date: 2020-07-07
• Public Version Status: Update
• Public Device Record Key: 0cea493b-a264-454d-b349-272cc7fb9f53

Device Description

Irradiation Aesthetic Device (Model: HairPro) consists of laser diodes that are spread throughout the cap. The device uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. In the process of the cap working, the indicator blinks red based on the working frequency of the laser diodes. Built-in timing function, the cap can record the time per treatment, and the cap can stop working automatically after ach 30 minutes treatment. When the built-in IR detected the cap is not worn on the head, the laser light output will be automatically suspended immediately and the cap will automatically shut down after 10 minutes.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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	06971777450029	GS1

Premarket Submissions

Submission Number	Supplement Number
K171835	000