FDA.reportPublic FDA data

LightStim Recovery Loop

Primary DI
00850030819086
Brand
LightStim Recovery Loop
Company
LED INTELLECTUAL PROPERTIES LLC
Model
One Pod
Catalog number
2013
Device description
Recovery Loop for Pain. Single Pod configuration.
Published
2025-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00850030819086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850030819086008500308190868500308190860850030819086

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
963347211
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850030819093LightStim Recovery LoopTwo Pods20142025-08-13
00850030819031LightStim for Acne / LightStim+ AcneLS4A / ALS-Pro2022-06-27
00850030819048LightStim for Wrinkles / LightStim+ Anti AgingLS4W / AALS-Pro2022-06-27
00850030819055LightStim+ ProPanel for Pain / Anti-AgingPP-PLS / PP-AALS2022-06-27
00850030819062LightStim for PainLS4P2022-06-27
00850030819079LightStim+ ProPanel for AcnePP-ALS2022-06-27
00850030819017LightStim LED BEDLSBED-P-182401-11352021-06-16
00850030819024LightStim & HydraFacial ElipsaElipsa Black1614-012022-03-07

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