HIGHERDOSE

Basic Information

• Brand Name: HIGHERDOSE
• Primary DI: 00850049532440
• Version / Model: HG-120K
• Company Name: Shenzhen Kaiyan Medical Equipment Co,. Ltd
• Labeler DUNS: 543062382
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-28
• Public Version: 2
• Public Version Date: 2025-11-24
• Public Version Status: Update
• Public Device Record Key: 26c8f3bc-f2ef-45e0-8ab9-acd1feae5fcd

Device Description

The HIGHERDOSE Red Light Hat is a home wearable light-emiting diode phototherapy device withproven wavelengths of light 650nm+10nm Red light, which are used to treat Androgenetic Alopecia andpromote hair growth in males who have Norwood- Hamilton Classifications of lla - V patterns of hair lossand to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale 1-1to 1-4, 1l-1, ll-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types l - IV.

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	00850049532440	GS1