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510(k) Data Aggregation
K Number
K960475Device Name
MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM
Manufacturer
LUXAR CORP.
Date Cleared
1996-04-26
(85 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
LUXAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the modified LX-20 is identical to that of the LX-20, namely the vaporization, incision, excision, ablation, or photocoagulation of soft tissue in the listed surgical specialties of:
- · Gynecology
- · Laparoscopic Surgery including GYN laparoscopy
- · Dermatology
- · Dental and oral surgery
- · Orthopedic
- · General Surgery
- · Otorhinolaryngology
- · Podiatry
No new indications were sought in the premarket notification and no clinical data were presented.
Device Description
The Luxar modified LX-20 surgical laser system produces laser (infrared) energy at a wavelength of 10.6 microns which is directed to soft tissue through a knuckled beam delivery assembly, hollow fiber waveguides, handpieces, and sterile delivery tips.
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