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510(k) Data Aggregation
K Number
K232301Device Name
Define RF Microneedling System
Manufacturer
Date Cleared
2024-03-14
(226 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Aesthetic Management Partners
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DefineRF is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
Device Description
DefineRF is a monopolar radiofrequency device that delivers up to 50W to the chosen location of the single needle tip. The device is equipped with touchscreen user interface, a footswitch, a handpiece, a needle type RF electrode, and an FDA cleared single use neutral electrode pad (K092761). The needle tip is single use and provided sterile. The system is designed for use in a clinical environment for use on adults.
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