Novilase Laser Therapy System, Model LTS-2
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K160392 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Novilase Laser Therapy System, Model LTS-2, is a medical device designed for the focal destruction of tumors. It is intended for the treatment of fibroadenomas of the breast, with tumor sizes up to 20 mm, and for general surgery procedures including incision.
The system is supplied by Novian Health Inc. and is authorized under FDA 510K and MDR. It is a reusable device that has been determined to be substantially equivalent in fundamental design and technology characteristics to the Kelsey Interstitial Laser Therapy System (Model ILT).
Frequently asked questions
What types of tumors can the Novilase Laser Therapy System, Model LTS-2, treat, and what are the size limitations for those tumors?
The Novilase Laser Therapy System, Model LTS-2, is specifically designed for the focal destruction of fibroadenomas in the breast, with a size limitation of up to 20 mm. It is also intended for general surgical procedures, including incision, but the tumor size restriction applies only to fibroadenomas.
Is the Novilase Laser Therapy System reusable or single-use, and how does this affect its maintenance?
The Novilase Laser Therapy System, Model LTS-2, is a reusable device. Since it is not single-use, proper cleaning, sterilization, and maintenance protocols must be followed to ensure its safe and effective use over multiple procedures, as outlined in the manufacturer’s instructions.
How is the Novilase Laser Therapy System, Model LTS-2, regulated, and what does its authorization status mean for clinicians?
The Novilase Laser Therapy System, Model LTS-2, holds FDA 510(k) clearance and MDR authorization, meaning it has been reviewed and deemed substantially equivalent to a previously approved device (the Kelsey Interstitial Laser Therapy System) for its intended uses. This status indicates it meets regulatory standards for safety and effectiveness as determined by the FDA and EU MDR.
Who is the manufacturer of the Novilase Laser Therapy System, and where can additional information or support be obtained?
The manufacturer of the Novilase Laser Therapy System, Model LTS-2, is Novian Health Inc., based in Chicago, IL. For inquiries or support, contact information is available through their official address at 430 W. Erie St., Suite 500, Chicago, IL 60654, or through the listed contact, William Graveman.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Novilase® Breast Therapy | Laser Ablation Surgery Alternative, Novian Health, Novilase Laser Therapy System, Model LTS-2 (K160392) — FDA 510 (k ..., PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K160392 | Class II | Active |
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Manufacturer
- Manufacturer
- Novian Health Inc.
- FDA Applicant
- Novian Health, Inc.
Sources (2)
- FDA 510(k) K160392 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026