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510(k) Data Aggregation
K Number
K141046Device Name
MIDI-SRS
Manufacturer
Date Cleared
2014-12-24
(245 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SRMC CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MiDi-SRS is intended for use in dermatological procedures requiring the coagulation of soft tissue.
Device Description
MiDi-SRS is designed to provide laser energy (1550nm) for use in a variety of dermatology and general surgery procedures. The product consists of main body, a tablet PC, a foot switch, an interlock switch and a key switch. The device fires a 1550nm Er- glass Fiber laser beam which is then split into a number of microscopic beams, producing tiny dot, or pixel-like treatment zones within the selected target area of the skin, leaving the other zones within it perfectly intact.
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