Capillus

GUDID 00810045461427

Red and blue light therapy device to reduce the appearance of fine lines and wrinkles and treat mild to moderate acne vulgaris.

CAPILLUS, LLC

Red/blue light phototherapy unit

• Primary Device ID: 00810045461427
• NIH Device Record Key: 160ef4c5-76dd-4e49-b0fb-b4d1441826f3
• Commercial Distribution Discontinuation: 2025-01-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Capillus
• Version Model Number: AST-804
• Company DUNS: 079813345
• Company Name: CAPILLUS, LLC
• 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	00810045461427 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213056

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: 2025-01-29
• Device Publish Date: 2025-01-21

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