# K160392: Novilase Laser Therapy System, Model LTS-2

- Pathway: 510(k) (Special)
- Applicant: Novian Health, Inc.
- Decided: Feb 26, 2016 after 15 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K943450 (1995). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070353: Kelsey Intersitital Laser Therapy System, Kelsey, Inc. (2007) Summary page 6.

## Indications for use
The Novilase® Laser Therapy System (LTS-2) is indicated for the treatment of fibroadenomas of the breast, with tumor sizes up to 20 mm, and for general surgery procedures including incision, excision and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissues.

Source page: https://510kreport.com/device/K160392
Methodology: https://510kreport.com/methodology