Novilase 100001-03

GUDID 00860008944887

Novilase Laser Therapy System for focal destruction breast tumors. For distribution in the UK.

Novian Health Inc.

General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system

• Primary Device ID: 00860008944887
• NIH Device Record Key: d82e62c3-fce0-44b4-88ab-d770863e22e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novilase
• Version Model Number: LTS 2.1 (UK)
• Catalog Number: 100001-03
• Company DUNS: 011736427
• Company Name: Novian Health 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 3122667200
• Email: info@novianhealth.com
• Phone: 3122667200
• Email: info@novianhealth.com
• Phone: 3122667200
• Email: info@novianhealth.com
• Phone: 3122667200
• Email: info@novianhealth.com
• Phone: 3122667200
• Email: info@novianhealth.com
• Phone: 3122667200
• Email: info@novianhealth.com
• Phone: 3122667200
• Email: info@novianhealth.com
• Phone: 3122667200
• Email: info@novianhealth.com
• Phone: 3122667200
• Email: info@novianhealth.com
• Phone: 3122667200
• Email: info@novianhealth.com
• Phone: 3122667200
• Email: info@novianhealth.com
• Phone: 3122667200
• Email: info@novianhealth.com
• Phone: 3122667200
• Email: info@novianhealth.com
• Phone: 3122667200
• Email: info@novianhealth.com
• Phone: 3122667200
• Email: info@novianhealth.com
• Phone: 3122667200
• Email: info@novianhealth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008944887 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160392

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: 2023-11-23
• Device Publish Date: 2023-11-15

On-Brand Devices [Novilase]

• 00860008944825: Novilase Laser Therapy System for focal destruction breast tumors.
• 00860008944887: Novilase Laser Therapy System for focal destruction breast tumors. For distribution in the UK.
• 00860008944870: Novilase Laser Therapy System for focal destruction breast tumors. For distribution in Europe an