Manufacturer
Novian Health, Inc.Novilase Laser Therapy System, Model LTS-2
Country / Region:United States (US)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K160392
- Device name
- Novilase Laser Therapy System, Model LTS-2
- Company
- Novian Health, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2016-02-11
- Decision date
- 2016-02-26
- Submission type
- Special
- Technology type
- Other(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
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.
Intended 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.
Device Description
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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Cited as predicate
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