FDA.reportPublic FDA data

Velara Elite 32

Primary DI
G710E320
Brand
Velara Elite 32
Company
SUNSHINE USA, LLC
Model
E32
Catalog number
E32
Device description
This is a Class II infrared therapeutic heating lamp (Product Code ILY, 21 CFR 890.5500) intended for localized heat therapy to relieve muscle pain, joint stiffness, and improve local blood circulation.
Published
2026-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
G710E320PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
104258633
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G710L240Velara Lounge 24L24L242026-05-15
G710A480Velara Ascend 48A48A482026-05-11
G71032C0SOLAR STORM 32CSS32CSS32C2025-08-14
G710AV160AVALON 16AV16AV162025-08-14
G710AV200AVALON 20AV20AV202025-08-14
G710AV240AVALON 24AV24AV242025-08-14
G710AV280AVALON 28AV28AV282025-08-14
G710AV32AVALON 32AV32AV322025-08-14
G710GAL160GALAXY 16GA16GA162025-08-14
G710GAL180GALAXY 18GA18GA182025-08-14
G710GAL220GALAXY 22GA22GA222025-08-14
G710GAL240GALAXY 24GA24GA242025-08-14
G710GAL300GALAXY 30GA30GA302025-08-14
G710OA360OASIS 36OA36OA362025-08-14
G710SF32X0SUNFIRE 32X PLATINUMSF32XSF32X2025-08-14
G710SS300SOLAR STORM 30SS30SS302025-08-14
G710SS32R0SOLAR STORM 32RSS32RSS32R2025-08-14
G710SS32S0SOLAR STORM 32SSS32SSS32S2025-08-14
G710SS36ST0SOLAR STORM 36STSS36STSS36ST2025-08-14
G710SS48ST0SOLAR STORM 48STSS48STSS48ST2025-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00860179001013FUSION PBM Plus LightDentlight Inc.ILY2026-05-27
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B317KLGEHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGUHUF0GIROELTECH KLASER SRLILY2026-05-27
G710L240Velara Lounge 24SUNSHINE USA, LLCILY2026-05-15
G710A480Velara Ascend 48SUNSHINE USA, LLCILY2026-05-11
00810140063014RENPHOJoicom CorporationILY2026-05-08
00850001456784MODEL S+ BY SPIRULUX Omm Imports Inc.ILY2026-05-03
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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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