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510(k) Data Aggregation
K Number
K012545Device Name
ARAMIS DERMATLOGIC LASER
Manufacturer
LUMEDICS, LTD.
Date Cleared
2001-11-05
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
LUMEDICS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aramis is intended to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis Laser is also indicated for the photocoagulation of dermatological vascular lesions, including photothermolysis of blood vessels (treatment of facial and leg veins) and the treatment of benign pigmented lesions.
The Aramis Dermatologic Laser system is intended to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis Laser is also indicated for the removal of pigmented lesions; photocoagulation of dermatological vascular lesions, including photothermolysis of blood vessels (treatment of facial and leg veins).
Device Description
The Aramis Dermatologic Laser is an Er-glass 1.54 um system. The computer system consists of a laser unit, a cooler, a footswitch, and a 2mm or 4mm hand piece. The 4mm hand piece is gas-cooled to provide actual skin cooling. Laser parameters and other system features are controlled from the touch-buttons on top of the laser unit, which provides an interface to the system computer.
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