FDA.reportPublic FDA data

SynRG Light Pad

Primary DI
00860000214025
Brand
SynRG Light Pad
Company
Rst- Sanexas
Model
55105
Published
2019-09-13
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860000214022PackageGS110In Commercial Distribution
00860000214025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000021402210860000214022
00860000214025008600002140258600002140250860000214025

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
109562944
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860000214032RST-SANEXAS BasicRST-SANEXAS Basic2021-04-16
00860000214049RST-SANEXAS PTRST-SANEXAS PT2021-04-16
00860000214056SynRG Light Pad551052021-09-20
00860000214001neoGENneoGEN2019-04-25
00860000214018VPX VasopulseVPX Vasopulse2019-04-25

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Primary DI, Brand, Company table
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B317KLGUHUF0GIROELTECH KLASER SRLILY2026-05-27
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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
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