Newdermo

GUDID 16974020960914

LED light therapy mask

Guangdong Newdermo Biotech Co.,Ltd.

Blue/red/infrared phototherapy lamp

• Primary Device ID: 16974020960914
• NIH Device Record Key: 96c022e5-e363-4adb-8bd9-909cf8f03734
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Newdermo
• Version Model Number: FM-01
• Company DUNS: 403370499
• Company Name: Guangdong Newdermo Biotech 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974020960917 [Primary]
GS1	16974020960914 [Package]; Contains: 06974020960917; Package: outer packing [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223544

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: 2023-09-04
• Device Publish Date: 2023-08-25

Devices Manufactured by Guangdong Newdermo Biotech Co.,Ltd.

• 06974020961075 - N/A: 2025-10-06 FM-02 ; LED light therapy mask
• 06974020961082 - N/A: 2025-10-06 FM-03 ; LED light therapy mask
• 06974020961105 - N/A: 2025-10-06 FM-02 ; LED light therapy mask
• 16974020961034 - N/A: 2024-08-05 FM-02 ; LED light therapy mask
• 06974020961044 - N/A: 2024-08-05 FM-02 ; LED light therapy mask
• 06974020961068 - N/A: 2024-08-05 FM-01 ; LED LIGHT THERAPY MASK
• 06974020961020 - INIA: 2024-03-26 INIA GLOW LED light therapy mask
• 16974020961003 - WONDER FAMILY: 2023-10-24 Nomadparadise Corp LED LIGHT THERAPY MASK