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Myolight

FDA UDI

Class II (US FDA UDI)

by RAJA Medical

Identity

Trade Name
MYOLIGHT FDA UDI
Generic Name
Transcutaneous electrical stimulation electrode, reusable FDA UDI
Device Name
The MyoLight Handpiece delivers microcurrent stimulation to the patient’s face and body. FDA UDI
Model / Reference
MYOLIGHT HANDLE FDA UDI
Description
The MyoLight Handpiece delivers microcurrent stimulation to the patient’s face and body. FDA UDI

Identifiers

Catalog Number
MYOLIGHT HANDLE FDA UDI
Primary DI / UDI-DI
G050MYOLIGHT0 FDA UDI
510(k) Number
K243063 FDA UDI
FDA Product Code
NFO FDA UDI
GMDN Term
Transcutaneous electrical stimulation electrode, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Transcutaneous electrical stimulation electrode, reusable

Myolight by RAJA Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transcutaneous electrical stimulation electrode, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
RAJA Medical

Sources (1)

  • FDA UDI 0fc8c63f-31cd-4eaf-bdda-bd0b6f407bb9 35 fields · synced Jun 6, 2026