FDA.reportPublic FDA data

OXYLIGHT

Primary DI
G050DOXYLIGHTIONIX0
Brand
OXYLIGHT
Company
RAJA Medical
Model
D OXYLIGHT IONIX
Catalog number
D OXYLIGHT IONIX
Device description
The DIOR OXYLIGHT IONIX 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.
Published
2025-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument
GFEBrush, Dermabrasion, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
GFEBrush, Dermabrasion, PoweredGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202175000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202175000OxyLight 2.0Raja Trading Company, Inc.2021-12-02GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G050DOXYLIGHTIONIX0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemAn electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabrasion, oxygen skin application] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes energy/therapy sources (e.g., lasers, lamps, generator) and dedicated applicators (handpieces) intended to apply the different therapies to the skin.

Regulatory Flags#

DUNS number
780355074
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G050JUVESAPROSKIN0OXYLIGHTJUVESA PROSKINJUVESA PROSKIN2025-03-13
G050MYOLIGHT0MYOLIGHT MYOLIGHT HANDLEMYOLIGHT HANDLE2025-03-13
G050IONIXLIGHT0OXYLIGHTIONIXLIGHTIONIXLIGHT2024-04-07
G050OXYLIGHTIONIX0OXYLIGHTOXYLIGHT IONIXOXYLIGHT IONIX2024-04-07
G050OXYLIGHT0OXYLIGHTOXYLIGHT2021-09-09

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Primary DI, Brand, Company table
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