illuvinate System

GUDID 00860228002107

LUMA THERAPEUTICS, INC.

Light-energy skin surface treatment system applicator

• Primary Device ID: 00860228002107
• NIH Device Record Key: c33959cd-8509-4ecf-bf8c-883d75a11aea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: illuvinate System
• Version Model Number: CAT0581
• Company DUNS: 079825299
• Company Name: LUMA THERAPEUTICS, INC.
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860228002107 [Primary]

FDA Product Code

• FTC: Light, Ultraviolet, Dermatological

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: 2019-03-11
• Device Publish Date: 2019-02-28