FDA.reportPublic FDA data

ZONN

Primary DI
06975188960122
Brand
ZONN
Company
Zonnsmart Science & Technology Co.,Ltd
Model
HL811 PRO
Device description
This product is a far-infrared penetration instrument, which mainly provides topical heating of the head to increase tissue temperature, and to adjust head massage mode, promoting scalp tissue relaxation, and temporarily increasing local blood circulation.
Published
2024-09-10
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
06975188961129PackageGS18In Commercial Distribution
06975188960122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975188961129069751889611296975188961129
06975188960122069751889601226975188960122

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
714639269
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975188960061ZONNHL700 PRO 2024-09-10
06975188960078ZONNHL850 PRO MAX2024-09-10
06975188960085ZONNHL850 PRO2024-09-10
06975188960092ZONNHL880 PRO MAX2024-09-10
06975188960108ZONNHL800 PRO 2024-09-10
06975188960115ZONNHL811 PRO MAX2024-09-10
06975188960139ZONNHL711 PRO MAX2024-09-10
06975188960146ZONNHL711 PRO2024-09-10
06975188960054ZONNHL700 PRO MAX2024-09-10
06975188961068ZONNHL700 PRO 2024-09-10
06975188961075ZONNHL850 PRO MAX2024-09-10
06975188961082ZONNHL850 PRO2024-09-10
06975188961099ZONNHL880 PRO MAX2024-09-10
06975188961105ZONNHL800 PRO 2024-09-10
06975188961112ZONNHL811 PRO MAX2024-09-10
06975188961129ZONNHL811 PRO2024-09-10
06975188961136ZONNHL711 PRO MAX2024-09-10
06975188961143ZONNHL711 PRO2024-09-10
06975188960016ZONNHL8002024-08-27
06975188960023ZONNHL800-BT 2024-08-27

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Primary DI, Brand, Company table
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06974958310624mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06979994630002CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
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08800190200004OLIZLTBIO Co., Ltd.ILY2026-08-26
06977782490029QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILY2026-08-22
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00860015688996HomedicsFKA DISTRIBUTING CO., LLCILY2026-08-01
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00810140063113RENPHOJoicom CorporationILY2026-07-24
00810140063120RENPHOJoicom CorporationILY2026-07-24
00850083596002LaserWrapSPECTRA THERAPY, LLCILY2026-07-24
00850083596026LaserWrapSPECTRA THERAPY, LLCILY2026-07-24
00850026680218Aura WellnessAura Wellness, LLCILY2026-07-21
08800020111852HILTHERAJeisys Medical Inc.ILY2026-07-21
00850087184038HomedicsFKA DISTRIBUTING CO., LLCILY2026-07-13
08800291820323HEALITE IICynosure Lutronic Technology CorporationILY2026-06-23
00860179001013FUSION PBM Plus LightDentlight Inc.ILY2026-05-27