Luminance RED Acne Device

GUDID 00860002593036

Luminance Medical Ventures Incorporated

Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit

• Primary Device ID: 00860002593036
• NIH Device Record Key: 07c78af3-249d-4036-851d-7ce843d40973
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luminance RED Acne Device
• Version Model Number: TN1927D
• Company DUNS: 065554288
• Company Name: Luminance Medical Ventures Incorporated
• 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: 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	00860002593036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220729

FDA Product Code

• OLP: Over-The-Counter Powered Light Based Laser For Acne

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: 2023-06-01
• Device Publish Date: 2023-05-24

Devices Manufactured by Luminance Medical Ventures Incorporated

• 00860002593005 - Luminance RED Lip Device: 2023-06-05
• 00860002593043 - Luminance RED Mouth Device: 2023-06-05
• 00860002593050 - Luminance RED Genital Device: 2023-06-05
• 00860002593074 - Luminance RED Tip: 2023-06-05
• 00860002593036 - Luminance RED Acne Device: 2023-06-01
• 00860002593036 - Luminance RED Acne Device: 2023-06-01