Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
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.
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.
The Novilase Laser Therapy System (Model LTS-2) is a second-generation laser-based system that uses laser ablation to destroy tumors via a minimally-invasive procedure.
Summary parsed at:2026-06-01 06:05:55 UTC
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