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510(k) Data Aggregation
K Number
K020673Device Name
WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER
Manufacturer
Date Cleared
2002-05-30
(90 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
WAVE FORM MFG., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Wave Form Manufacturing Prolase General Shaped Fiber is intended to be used for vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, ureteroscopes, bronchoscopes, cystoscopes, gastroscopes, arthroscopes, colonoscopes, or for open surgery in contact or non-contact surgery with or without handpieces for use in coagulation, incision/excision, ablation and vaporization of soft tissue.
The Wave Form Manufacturing PGS Fiber is indicated for use in medicine and surgery in the following specialties: Urology, Pulmonology, Arthroscopy, Podiatry, Orthopedics, Lithotripsy, ENT Surgery, Neurosurgery, Gastroenterology, Plastic Surgery, Dermatology, Radiology, Gynecology, and General and Vascular Surgery.
Device Description
The Wave Form Manufacturing Prolase General Shaped (PGS) Fiber is a fiber optic laser delivery system consisting of a 3 meter long silica fiber, clad in fluorinated doped silica, buffered with a fluorinated acrylate and a shaped tip. As an integral part of a laser system, the PGS fiber may be used for a wide variety of surgical procedures.
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