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Accent Radiofrequency (RF) System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K101147

by Alma Lasers, Inc.

Identifiers

510(k) Number
K101147 FDA 510(k)
FDA Product Code
NUV FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Accent Radiofrequency (RF) System is a class II medical device classified as a massager, vacuum, and light-induced heating device, designed for dermatologic and general surgical applications. It employs radiofrequency energy to deliver non-invasive treatments, including the reduction of wrinkles and rhytids, through unipolar and bipolar handpieces. The system is intended for use in controlled clinical settings where precise energy delivery is required for skin rejuvenation and tissue remodeling.

The Accent RF System is supplied as a reusable medical device and is intended for use in sterile environments, adhering to regulatory standards for class II devices under FDA 510(k) clearance (K101147). It is available in multiple models, including Accent, Accent XL, and Accent Elite, each with distinct specifications and energy delivery configurations. Storage and handling must comply with manufacturer guidelines to ensure device integrity and patient safety, with no explicit MRI safety information provided in the data.

Frequently asked questions

What is the Accent RF System used for?

The Accent RF System is a class II medical device designed for dermatologic and general surgical applications. It uses radiofrequency energy to provide non-invasive treatments, such as reducing wrinkles and rhytids, through specialized unipolar and bipolar handpieces. This technology is intended for controlled clinical environments where precise energy delivery is essential for skin rejuvenation and tissue remodeling.

Is the Accent RF System reusable or single-use?

The Accent RF System is supplied as a reusable medical device. It is intended for use in sterile environments, adhering to regulatory standards for class II devices. Proper storage and handling are required to maintain device integrity and ensure patient safety.

What models of the Accent RF System are available?

The Accent RF System comes in multiple models, including the Accent, Accent XL, and Accent Elite. Each model features distinct specifications and energy delivery configurations tailored for different clinical applications. The variations allow for flexibility in treating various dermatologic and surgical needs.

How should the Accent RF System be stored?

The Accent RF System must be stored and handled according to the manufacturer’s guidelines to preserve its integrity and ensure safety. Since it is a reusable device, proper sterilization protocols must be followed before each use in a sterile environment. Adherence to these guidelines is critical for maintaining device performance and preventing contamination.

Is there any information about MRI safety for the Accent RF System?

The provided data does not include explicit MRI safety information for the Accent RF System. Clinicians should consult the manufacturer’s instructions for use or additional documentation to determine compatibility with MRI environments before use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Modified Alma Lasers Family of Accent Radiofrequency (Rf) System, Alma Lasers Family of Accent Radiofrequency (Rf) Systems, Models ..., Accent XL by Alma Lasers Inc. | FDA 510 (k) Summary, MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Alma Lasers, Inc.

Sources (1)

  • FDA 510(k) K101147 24 fields · synced Oct 6, 2026