MIRIA

GUDID 00860010800515

Avava, Inc.

Dermatological diode laser system

• Primary Device ID: 00860010800515
• NIH Device Record Key: 36a0763e-ace4-4ed3-81d0-48ea7ca52b04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIRIA
• Version Model Number: N/A
• Company DUNS: 102380625
• Company Name: Avava, 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: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010800515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221268

FDA Product Code

• ONG: Powered Laser Surgical Instrument With Microbeam\Fractional Output

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: 2023-12-28
• Device Publish Date: 2023-12-20

On-Brand Devices [MIRIA]

• 00860010800515: N/A
• 00860010800508: N/A