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510(k) Data Aggregation
K Number
K231514Device Name
Azure
Manufacturer
Date Cleared
2024-02-14
(265 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Daeshin Enterprise Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Azure(DS-22CO) is intended for use in non-fractionated mode for Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues in Dermatology, Plastic surgery, General Surgery, Gynecology, Neurosurgery, and in Podiatry.
Device Description
Azure consists of main body, articulated arm, handpiece, foot switch, power cord, protective glasses. In a main body, there are a monitor displaying all information needed by an operator at a glance and a touch LCD manipulated by simple hand touch, which facilitates operation of the equipment at user's convenience. The laser output is released by the foot switch. This laser operation device uses CO2 medium based wave of 10.6 micrometers.
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