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510(k) Data Aggregation
K Number
K141658Device Name
LIGHT SCALPEL
Manufacturer
LIGHT SCALPEL LLC
Date Cleared
2014-10-22
(124 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
LIGHT SCALPEL LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LightScalpel LS-1005 & LS-2010 CO2 Laser Systems are in laser surgery procedures for incision, excision, vaporization, ablation, and/or coagulation of soft tissue in specialties such as; general surgery, dermatology, gynecology, dentistry and oral surgery, otorhinolaryngology, plastic and reconstructive surgery, neurosurgery, podiatry, and urology.
Device Description
The LightScalpel LS-1005 / LS-2010 laser systems are mobile platforms that utilizes a radio frequency (RF) excited carbon dioxide (CO2) laser tube to produce an infrared beam at a nominal 10.6 µm wavelength at powers adjustable from 2 to 10 and 2 to 20 Watts Continuous Wave (CW) respectively. The systems differ only in the laser tube used, pre-programmed values in the controlling software, which allow higher laser tube drive for the LS-2010 system, and physical height and weight. Laser energy is conducted to the point of application by a flexible fiber waveguide and handpiece assembly. Laser system operation is controlled by operator input on a touch-screen display panel. The RF laser drive is modulated to provide additional pulsed and superpulse emission modes selected from the laser system control panel.
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