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510(k) Data Aggregation
K Number
K152417Device Name
Adler MicroMed Laser Surgery Fibers
Manufacturer
ADLER MICROMED INC.
Date Cleared
2015-12-01
(97 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ADLER MICROMED INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fibers are indicated for use in general surgical applications for incision, vaporization, ablation, hemostasis or coagulation of soft tissue. It is also indicated for use in open or closed endoscopic applications including excision,tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated.
The Adler MicroMed Laser Surgery Fibers have a wavelength range of 450 nm to 2100 nm, can be used in contact and non-contact mode and are indicated for use in general surgery, urology, gastroenterology, gynecology, gynecology, drmnology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous veni in the patient with superficial vein reflux and laser assisted lipolysis with a cleared compatible laser marketed for the mononed intended uses and using an SMA 905 connector.
Device Description
The Adler MicroMed Laser Surgery Fibers are single use laser delivery devices provided sterile and intended for medical applications in various fields of laser surgerv.
The devices are based on a silica quartz glass core, have a length range of 6.5 feet (2 meters) to 9.8 feet (3 meters) and a wavelength range between 450 and 2100nm. The proximal end of the fibers is connected to a cleared laser system via an SMA 905 connector, while the distal end delivers the laser energy to the target tissue inn pulsed and continuous wave mode.
The distal end may have a rounded or conical silica cap, or non-capped tips, which may be flat, spherical, ball, conical or bended for the various intended uses and effects.
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