FDA.reportPublic FDA data

OXYLIGHT

Primary DI
G050IONIXLIGHT0
Brand
OXYLIGHT
Company
RAJA Medical
Model
IONIXLIGHT
Catalog number
IONIXLIGHT
Device description
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.
Published
2024-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
G050IONIXLIGHT0PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
561-373-5245eneida.soares@rajamedical.com

Regulatory Flags#

DUNS number
780355074
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G050DOXYLIGHTIONIX0OXYLIGHTD OXYLIGHT IONIXD OXYLIGHT IONIX2025-09-24
G050JUVESAPROSKIN0OXYLIGHTJUVESA PROSKINJUVESA PROSKIN2025-03-13
G050MYOLIGHT0MYOLIGHT MYOLIGHT HANDLEMYOLIGHT HANDLE2025-03-13
G050OXYLIGHTIONIX0OXYLIGHTOXYLIGHT IONIXOXYLIGHT IONIX2024-04-07
G050OXYLIGHT0OXYLIGHTOXYLIGHT2021-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
08053782384136T-FACEB&M SRL MARKETING NEL BENESSEREGFE2026-05-27
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08053782383733T-FACEB&M SRL MARKETING NEL BENESSEREGFE2026-03-25
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
08059173390243Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390274Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
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08059173390335Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
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08059173390427Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390458Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
08059173390021Youlaser CO2QUANTA SYSTEM SPAGEX2019-01-07