HIGHERDOSE

GUDID 00850049532471

The HlGHERDOSE Red And Infrared Light Mask (Model: MK66-L) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.

Shenzhen Kaiyan Medical Equipment Co,. Ltd

Blue/red/infrared phototherapy lamp

• Primary Device ID: 00850049532471
• NIH Device Record Key: 0ee252a9-24b9-4d25-b525-c8f5ce82eee4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HIGHERDOSE
• Version Model Number: MK66-L
• 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	00850049532471 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241933

FDA Product Code

• OHS: Light Based Over The Counter Wrinkle Reduction

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