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510(k) Data Aggregation
K Number
K233120Device Name
CWM-930S, FIXER DV9
Manufacturer
Date Cleared
2024-05-23
(239 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Chungwoo Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is intended for use in dermatologic and general surgical procedures for electro coagulation.
Device Description
This device is a Fractional RF Surgical Unit with Sterile Micro Needle, which is composed of the main device (generator and user interface display, handpiece, foot switch, neutral electrode, and monopolar microneedle electrodes. It is designed for applying radiofrequency therapy with microneedles, which coagulates skin tissue using 1 MHz or 2 MHz radiofrequency energy delivered from the generator to the microneedles. A Bipolar Handpiece suction filter is also available for use to remove unwanted debris from the skin application site and safeguarding the equipment by preventing foreign substances from entering during use.
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K Number
K222709Device Name
Retraction, CWM-910T, APOLEX Tite
Manufacturer
Date Cleared
2023-03-21
(194 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Chungwoo CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
Device Description
Retraction, CWM-910T and APOLEX Tite are RF electrosurgical system. These are identical except for model designation. The RF electrosurgical system consists of an electrosurgical device (ESU), 3 types of detachable handpieces (mono-polar active electrode), a grounding plate (neutral electrode) and a foot switch. The hand piece consists of a hand grip and an electrode. There are 3types of mono-polar electrode depend on diameter and length. The electrosurgical device generates 480KHz RF current. RF output energy (Max. 50W) is delivered through a mono-polar active electrode and returned through the grounding plate (neutral electrode).
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