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510(k) Data Aggregation
K Number
K092860Device Name
LASEMAR 800, 1000, 1500
Manufacturer
Date Cleared
2010-07-16
(302 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
EUFOTON S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Lasemar 800, Lasemar 1000, Lasemar 1500 (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for :surgical applications requiring the vaporization, incision, excition, cutting and hemostation, cutting and hemostasis, or specialistion of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracio Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedias, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Spinel Radiology, Endovascular coagulation, Oral Surgery, Dental procedures and Laser Assisted Linolysis Assisted Lipolysis.
Device Description
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