OXYLIGHT IONIXLIGHT

GUDID G050IONIXLIGHT0

The IONIXLIGHT System is a multi-modality skin surface treatment system that uses multiple therapeutic modalities delivered through different attachments or handles connected to a main body. The system includes an LED panel/ lamp that irradiates Blue, Red and Yellow LED light and a Negative ION Mist. The system also includes various handles that deliver a variety of therapeutic modalities including microdermabrasion, LED light and Oxygen spray.

RAJA Medical

Multi-modality skin surface treatment system

• Primary Device ID: G050IONIXLIGHT0
• NIH Device Record Key: 4144cb52-8a8d-4a03-b520-962ec0ed6f03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OXYLIGHT
• Version Model Number: IONIXLIGHT
• Catalog Number: IONIXLIGHT
• Company DUNS: 780355074
• Company Name: RAJA Medical
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: 561-373-5245
• Email: eneida.soares@rajamedical.com
• Phone: 561-373-5245
• Email: eneida.soares@rajamedical.com
• Phone: 561-373-5245
• Email: eneida.soares@rajamedical.com
• Phone: 561-373-5245
• Email: eneida.soares@rajamedical.com
• Phone: 561-373-5245
• Email: eneida.soares@rajamedical.com
• Phone: 561-373-5245
• Email: eneida.soares@rajamedical.com
• Phone: 561-373-5245
• Email: eneida.soares@rajamedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G050IONIXLIGHT0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202175

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2024-04-15
• Device Publish Date: 2024-04-07

On-Brand Devices [OXYLIGHT]

• G050OXYLIGHT0: The OxyLight system is a skin care therapy system that that uses multiple therapeutic modalities
• G050OXYLIGHTIONIX0: The OXYLIGHT IONIX System is a multi-modality skin surface treatment system that uses multiple t
• G050IONIXLIGHT0: The IONIXLIGHT System is a multi-modality skin surface treatment system that uses multiple thera