FDA.reportPublic FDA data

Platinum LED Therapy Lights

Primary DI
B842BIOMAX4500
Brand
Platinum LED Therapy Lights
Company
PLATINUM LED HOLDINGS LLC
Model
BIOMAX450
Catalog number
BIOMAX450
Device description
BIOMAX450
Published
2020-06-04
Public version status
Update
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
B842BIOMAX4500PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blue/red/infrared phototherapy lampA portable mains electricity (AC-powered) device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, and musculoskeletal symptoms (e.g., pain, spasm, stiffness). It is normally available [non-prescription] over-the-counter (OTC) for use by the patient in the home or by a healthcare professional in a clinical setting.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Weight17Pound

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit130 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-844-533-4769support@platinumtherapylights.com

Regulatory Flags#

DUNS number
024319954
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
B842BIO300NIR0Platinum LED Therapy LightsBIO300NIRBIO300NIR2020-06-04
B842BIO300R0Platinum LED Therapy LightsBIO300RBIO300R2020-06-04
B842BIO300RNIR0Platinum LED Therapy LightsBIO300RNIRBIO300RNIR2020-06-04
B842BIO450NIR0Platinum LED Therapy LightsBIO450NIRBIO450NIR2020-06-04
B842BIO450R0Platinum LED Therapy LightsBIO450RBIO450R2020-06-04
B842BIO450RNIR0Platinum LED Therapy LightsBIO450RNIRBIO450RNIR2020-06-04
B842BIO600NIR0Platinum LED Therapy LightsBIO600NIRBIO600NIR2020-06-04
B842BIO600R0Platinum LED Therapy LightsBIO600RBIO600R2020-06-04
B842BIO600RNIR0Platinum LED Therapy LightsBIO600RNIRBIO600RNIR2020-06-04
B842BIO900NIR0Platinum LED Therapy LightsBIO900NIRBIO900NIR2020-06-04
B842BIO900R0Platinum LED Therapy LightsBIO900RBIO900R2020-06-04
B842BIO900RNIR0Platinum LED Therapy LightsBIO900RNIRBIO900RNIR2020-06-04
B842BIOMAX3000Platinum LED Therapy LightsBIOMAX300BIOMAX3002020-06-04
B842BIOMAX6000Platinum LED Therapy LightsBIOMAX600BIOMAX6002020-06-04
B842BIOMAX9000Platinum LED Therapy LightsBIOMAX900BIOMAX9002020-06-04

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Primary DI, Brand, Company table
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