FDA.reportPublic FDA data

LS Pro Systems

Primary DI
00850061407030
Brand
LS Pro Systems
Company
WELLNESS WITHOUT LIMITS LLC
Model
G264
Device description
LS Pro Systems General Red 264 red/infrared LED flexi-pad. Intended to deliver heat in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. Must be used with LS power controller.
Published
2024-05-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00850061407030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850061407030008500614070308500614070300850061407030

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

Regulatory Flags#

DUNS number
020287489
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850061407122LS Pro SystemsPB-MXP1002024-06-27
00850061407139LS Pro SystemsPB-MXP1712024-06-27
00850061407207LS Pro SystemsDSD1202024-06-27
00850061407009LS Pro SystemsXP12024-05-09
00850061407016LS Pro SystemsXP32024-05-09
00850061407023LS Pro SystemsXP62024-05-09
00850061407047LS Pro SystemsG264B2024-05-09
00850061407054LS Pro SystemsXL2002024-05-09
00850061407061LS Pro SystemsL1322024-05-09
00850061407078LS Pro SystemsL132B2024-05-09
00850061407085LS Pro SystemsF1042024-05-09
00850061407092LS Pro SystemsT902024-05-09
00850061407108LS Pro SystemsH1552024-05-09
00850061407115LS Pro SystemsB1122024-05-09
00850061407153LS Pro SystemsG264-SI2024-05-09
00850061407160LS Pro SystemsXL200-SI2024-05-09
00850061407177LS Pro SystemsH155-SI2024-05-09
00850061407184LS Pro SystemsUB128-SI2024-05-09
00850061407191LS Pro SystemsLB114-SI2024-05-09
00850061407214LS Pro SystemsF122-SI2024-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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G710E320Velara Elite 32SUNSHINE USA, LLCILY2026-05-11
00810140063014RENPHOJoicom CorporationILY2026-05-08
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B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCILY2026-04-23
B347BDRCK0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
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G180DIOWAVESTEALTHMAX0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-11-12
G180DIOWAVE50WLS0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-10-31
08906172600074LightdoctorLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDILY2025-10-10
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16978368600020 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05
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