FDA.reportPublic FDA data

MYOLIGHT

Primary DI
G050MYOLIGHT0
Brand
MYOLIGHT
Company
RAJA Medical
Model
MYOLIGHT HANDLE
Catalog number
MYOLIGHT HANDLE
Device description
The MyoLight Handpiece delivers microcurrent stimulation to the patient’s face and body.
Published
2025-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFOStimulator, Transcutaneous Electrical, Aesthetic PurposesNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243063000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243063000Myolight Microcurrent HandpieceRaja Trading Company, Inc.2025-02-10NFO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G050MYOLIGHT0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrode, reusableAn electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
780355074
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G050DOXYLIGHTIONIX0OXYLIGHTD OXYLIGHT IONIXD OXYLIGHT IONIX2025-09-24
G050JUVESAPROSKIN0OXYLIGHTJUVESA PROSKINJUVESA PROSKIN2025-03-13
G050IONIXLIGHT0OXYLIGHTIONIXLIGHTIONIXLIGHT2024-04-07
G050OXYLIGHTIONIX0OXYLIGHTOXYLIGHT IONIXOXYLIGHT IONIX2024-04-07
G050OXYLIGHT0OXYLIGHTOXYLIGHT2021-09-09

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Primary DI, Brand, Company table
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