HIGHERDOSE

GUDID 00850049532440

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.

Shenzhen Kaiyan Medical Equipment Co,. Ltd

Hair growth laser device

• Primary Device ID: 00850049532440
• NIH Device Record Key: 26c8f3bc-f2ef-45e0-8ab9-acd1feae5fcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HIGHERDOSE
• Version Model Number: HG-120K
• Company DUNS: 543062382
• Company Name: Shenzhen Kaiyan Medical Equipment Co,. Ltd
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850049532440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242363

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: 2025-07-07
• Device Publish Date: 2025-06-28

On-Brand Devices [HIGHERDOSE]

• 00860006793548: MK66-L
• 00850049532297: ZLD-75W
• 00850049532471: The HlGHERDOSE Red And Infrared Light Mask (Model: MK66-L) is an over the counter device that is
• 00850049532440: The HIGHERDOSE Red Light Hat is a home wearable light-emiting diode phototherapy device withprov