HIGHERDOSE

GUDID 00860006793548

Shenzhen Kaiyan Medical Equipment Co,. Ltd

Cosmetic red-light phototherapy system, home-use

• Primary Device ID: 00860006793548
• NIH Device Record Key: e15765a9-2a48-41a1-8f61-73f5889327dc
• 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: true
• 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: true
• Serial Number: true
• Manufacturing Date: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860006793548 [Primary]

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: 2024-01-31
• Device Publish Date: 2024-01-23

On-Brand Devices [HIGHERDOSE]

• 00860006793548: MK66-L
• 00850049532297: ZLD-75W