MYOLIGHT MYOLIGHT HANDLE

GUDID G050MYOLIGHT0

The MyoLight Handpiece delivers microcurrent stimulation to the patient’s face and body.

RAJA Medical

Transcutaneous electrical stimulation electrode, reusable

• Primary Device ID: G050MYOLIGHT0
• NIH Device Record Key: 0fc8c63f-31cd-4eaf-bdda-bd0b6f407bb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MYOLIGHT
• Version Model Number: MYOLIGHT HANDLE
• Catalog Number: MYOLIGHT HANDLE
• Company DUNS: 780355074
• Company Name: RAJA Medical
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G050MYOLIGHT0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243063

FDA Product Code

• NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-21
• Device Publish Date: 2025-03-13

Devices Manufactured by RAJA Medical

• G050JUVESAPROSKIN0 - OXYLIGHT: 2025-03-21 The JUVESAPROSKIN System is a multi-modality skin surface treatment system that uses multiple therapeutic modalities delivered t
• G050MYOLIGHT0 - MYOLIGHT: 2025-03-21The MyoLight Handpiece delivers microcurrent stimulation to the patient’s face and body.
• G050MYOLIGHT0 - MYOLIGHT: 2025-03-21 The MyoLight Handpiece delivers microcurrent stimulation to the patient’s face and body.
• G050IONIXLIGHT0 - OXYLIGHT: 2024-04-15 The IONIXLIGHT System is a multi-modality skin surface treatment system that uses multiple therapeutic modalities delivered thro
• G050OXYLIGHTIONIX0 - OXYLIGHT: 2024-04-15 The OXYLIGHT IONIX System is a multi-modality skin surface treatment system that uses multiple therapeutic modalities delivered
• G050OXYLIGHT0 - OXYLIGHT: 2021-09-17 The OxyLight system is a skin care therapy system that that uses multiple therapeutic modalities delivered through different att