InnoVoyce VYLO Laser ASY-300134

GUDID 00860004755982

InnoVoyce VYLO 30W 455nm Laser

Innovoyce LLC

General/multiple surgical diode laser system

• Primary Device ID: 00860004755982
• NIH Device Record Key: 1fbf2ed8-81de-4183-9400-3b8f1d383962
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InnoVoyce VYLO Laser
• Version Model Number: A
• Catalog Number: ASY-300134
• Company DUNS: 118104468
• Company Name: Innovoyce 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 617 865 9401
• Email: info@innovoyce.com
• Phone: 617 865 9401
• Email: info@innovoyce.com
• Phone: 617 865 9401
• Email: info@innovoyce.com
• Phone: 617 865 9401
• Email: info@innovoyce.com
• Phone: 617 865 9401
• Email: info@innovoyce.com
• Phone: 617 865 9401
• Email: info@innovoyce.com
• Phone: 617 865 9401
• Email: info@innovoyce.com
• Phone: 617 865 9401
• Email: info@innovoyce.com
• Phone: 617 865 9401
• Email: info@innovoyce.com
• Phone: 617 865 9401
• Email: info@innovoyce.com
• Phone: 617 865 9401
• Email: info@innovoyce.com
• Phone: 617 865 9401
• Email: info@innovoyce.com
• Phone: 617 865 9401
• Email: info@innovoyce.com
• Phone: 617 865 9401
• Email: info@innovoyce.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860004755982 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240159

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2025-02-17
• Device Publish Date: 2025-02-07

Devices Manufactured by Innovoyce LLC

• 00860004755982 - InnoVoyce VYLO Laser: 2025-02-17InnoVoyce VYLO 30W 455nm Laser
• 00860004755982 - InnoVoyce VYLO Laser: 2025-02-17 InnoVoyce VYLO 30W 455nm Laser
• 00860004755999 - InnoVoyce VYLO Eye Safety Filter Leica: 2025-02-17 InnoVoyce VYLO Eye Safety Filter Leica
• 00860011812104 - InnoVoyce VYLO Eye Safety Filter Zeiss: 2025-02-17 InnoVoyce VYLO Eye Safety Filter Zeiss
• 00860011812111 - InnoVoyce VYLO Footswitch: 2025-02-17 InnoVoyce VYLO Footswitch
• 00860011812180 - InnoVoyce VYLO Cart: 2025-02-17 InnoVoyce VYLO Cart
• 00860004755913 - InnoVoyce LLC: 2024-08-20 KTP Laser Fiber 600
• 00860004755906 - InnoVoyce LLC: 2024-08-05 KTP Laser Fiber 400
• 10860004755903 - InnoVoyce LLC: 2024-08-05 KTP Laser Fiber 600