FDA.reportPublic FDA data

OXYLIGHT

Primary DI
G050JUVESAPROSKIN0
Brand
OXYLIGHT
Company
RAJA Medical
Model
JUVESA PROSKIN
Catalog number
JUVESA PROSKIN
Device description
The JUVESAPROSKIN 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 various handles that deliver a variety of therapeutic modalities including microdermabrasion, LED light and Oxygen spray.
Published
2025-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G050JUVESAPROSKIN0PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
780355074
Device count
1
DM exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G050DOXYLIGHTIONIX0OXYLIGHTD OXYLIGHT IONIXD OXYLIGHT IONIX2025-09-24
G050MYOLIGHT0MYOLIGHT MYOLIGHT HANDLEMYOLIGHT HANDLE2025-03-13
G050IONIXLIGHT0OXYLIGHTIONIXLIGHTIONIXLIGHT2024-04-07
G050OXYLIGHTIONIX0OXYLIGHTOXYLIGHT IONIXOXYLIGHT IONIX2024-04-07
G050OXYLIGHT0OXYLIGHTOXYLIGHT2021-09-09

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