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Define RF Microneedling System

by Aesthetic Management Partners

510(k) K232301

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK232301 Date14 Mar 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Define RF Microneedling System is an electrosurgical cutting and coagulation device that combines RF energy with precision microneedling for skin tightening and rejuvenation. It is designed for use in aesthetic procedures and is safe for all skin types with minimal downtime.

This Class II device with product code GEI is supplied as a system for professional use in clinical settings. The device is authorized under FDA 510(k) clearance with regulation number 21 CFR 878.4400 and is manufactured by Aesthetic Management Partners in Cordova, Tennessee.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Define RF Microneedling System used for?

    The Define RF Microneedling System is an electrosurgical cutting and coagulation device that combines RF energy with precision microneedling for skin tightening and rejuvenation procedures. It is designed for professional use in clinical settings and is safe for all skin types with minimal downtime.

  • How is the Define RF Microneedling System supplied?

    The Define RF Microneedling System is supplied as a complete system for professional use in clinical settings. It is a Class II device with product code GEI, manufactured by Aesthetic Management Partners in Cordova, Tennessee.

  • What is the regulatory status of the Define RF Microneedling System?

    The Define RF Microneedling System is authorized under FDA 510(k) clearance with regulation number 21 CFR 878.4400. It received traditional clearance on March 14, 2024, with decision code SESE, indicating it is substantially equivalent to predicate devices.

  • Is the Define RF Microneedling System reusable or single-use?

    The device information does not specify whether the Define RF Microneedling System is reusable or single-use. For proper usage and disposal instructions, please consult the manufacturer's guidelines or contact Aesthetic Management Partners directly.