Benilight

Primary DI
08809922440053
Brand
Benilight
Company
Benilight
Model
iLED-Pro Mini
Device description
This device is an LED phototherapy unit that is used to relieve or reduce muscle pain by illuminating infrared ray. This device comprises a controller, an LED pad, an adapter and a band. The controller is connected to the LED pad that runs for 5 minutes, 15 minutes, or 30 minutes, for LO or HI, for 500Hz, 100Hz, 40Hz, 10Hz, or 2.5Hz. The wavelengths of the unit include 660nm (red), 850nm (NIR), and 940nm (NIR). The LED pad receives electrical signals from the controller and generates red and near-infrared light.
Published
2024-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809922440053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809922440053088099224400538809922440053

GMDN Terms#

Term, Definition table
TermDefinition
Red/infrared light phototherapy unitAn electrically-powered device designed to emit red light and infrared/near-infrared light for phototherapy primarily to accelerate healing of cutaneous/mucosal tissues and/or to treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood flow. It may have various designs (e.g., hand-held, arched bar, flexible pad for adapting to body areas) and is intended for use in the home and clinical settings.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+821037229599slim@benilight.com

Regulatory Flags#

DUNS number
695132580
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809922440060BenilightLife Beam2025-04-03
08809922440039BenilightiLED-Pro2024-10-01
08809922440046BenilightiLED2024-10-01

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