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K Number
K241157
Device Name
Secret MAX Multi-platform RF System
Manufacturer
Ilooda Co,.Ltd.
Date Cleared
2024-11-21

(209 days)

Product Code
GEI,OUH,PBX
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Secret MAX DEEPLUS MENU and SMARTCURE MENU are intended use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.

The WAVPLUS MENU is intended for the treatment of the following medical condition; using the handpiece for delivery of non-thermal RF energy combined with massage;

· Relief of minor muscle aches and pain, relief of muscle spasm

· Temporary improvement of local blood circulation

· Temporary reduction in the appearance of cellulite

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the "Secret MAX Multi-platform RF System", outlining its regulatory status and intended use. It does not include details about device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.