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510(k) Data Aggregation
K Number
K240311Device Name
JETT Medical II
Manufacturer
Date Cleared
2025-01-22
(355 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
COMPEX, spol, s.r.o.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
JETT Medical II is intended for non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV.
Device Description
JETT Medical II is a portable medical device designed for non-ablative treatment of wrinkles and rhytids. The device works on the physical principle of a sequence of DC microcurrents, which are generated by electrically or battery powered generator and that are transmited to the patient skin through indifferent conductive gel. Patient loop is formed by pairing the handpiece with one of flat applicators with the grounding electrode (cylinder or disposable). Device consists of the standard package and optional accessories.
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