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Myolight Microcurrent Handpiece

by Raja Trading Company, Inc. 510(k)

Active United States

510(k) K243063

Overview

The Myolight Microcurrent Handpiece is a Stimulator, Transcutaneous Electrical designed for aesthetic purposes. It delivers microcurrent therapy to stimulate muscle contraction and enhance skin rejuvenation, promoting collagen production and tissue repair through low-intensity electrical impulses.

This device is intended for single-use or reusable applications in clinical or aesthetic settings, depending on manufacturer guidelines. Supplied sterile or non-sterile as specified, it operates under FDA clearance (510(k) K243063) and adheres to regulatory classification NFO under 882.5890. No MRI safety information is provided, and sizes or additional technical specifications are not detailed in the available data.

AI-generated from registry data, 20 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK243063 Date10 Feb 2025ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
NFO
Device Class
Class II
Regulation
21 CFR Part 882.5890
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Other devices from Raja Trading Company, Inc.

  • Oxylight

    Class II

  • OxyLight 2.0

    Class II

Questions

  • What is the primary purpose of the Myolight Microcurrent Handpiece, and how does it work?

    The Myolight Microcurrent Handpiece is designed for aesthetic purposes, delivering microcurrent therapy to stimulate muscle contractions and promote skin rejuvenation. It works by applying low-intensity electrical impulses to encourage collagen production and tissue repair, helping improve skin appearance.

  • Is the Myolight Microcurrent Handpiece intended for single-use or reusable applications, and how should it be handled?

    The device can be used for either single-use or reusable applications, depending on the manufacturer’s guidelines. If reusable, it must be cleaned and sterilized properly between uses to maintain safety and effectiveness. The supplied sterility (sterile or non-sterile) should be followed as directed by the manufacturer.

  • What regulatory pathway was followed for FDA clearance of the Myolight Microcurrent Handpiece?

    The Myolight Microcurrent Handpiece received FDA clearance through a 510(k) submission (K243063), classified under Traditional review and determined to be Substantially Equivalent to a predicate device. It falls under the Neurology advisory committee and is categorized under product code NFO with regulation number 882.5890.

  • Are there any specific storage instructions or considerations for the Myolight Microcurrent Handpiece?

    The provided data does not specify storage instructions, but since the device is used in clinical or aesthetic settings, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. If sterile, follow manufacturer guidelines for maintaining sterility until first use.