FDA.reportPublic FDA data

LightStim LED BED

Primary DI
00850030819017
Brand
LightStim LED BED
Company
LED INTELLECTUAL PROPERTIES LLC
Model
LSBED-P-18240
Catalog number
1-1135
Published
2021-06-16
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153399000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153399000LightStim Professional LED BedLed Intellectual Properties, LLC2016-07-05ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850030819017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850030819017008500308190178500308190170850030819017

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal infrared phototherapy unit, non-wearableA mains electricity (AC-powered) device intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
963347211
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850030819086LightStim Recovery LoopOne Pod20132025-08-13
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
00850030819024LightStim & HydraFacial ElipsaElipsa Black1614-012022-03-07

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