FDA.reportPublic FDA data

BON CHARGE

Primary DI
09361725000067
Brand
BON CHARGE
Company
BLUBLOX PTY LTD
Model
Red Light Therapy Blanket
Published
2024-12-17
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
09361725000067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09361725000067093617250000679361725000067

GMDN Terms#

Term, Definition table
TermDefinition
Cosmetic red-light phototherapy system, home-useAn assembly of mains electricity (AC-powered) devices designed to emit low-level broad-band (LLBB) red light in the visible and invisible spectra together with heat [light and heat energy (LHE)] for the cosmetic treatment of dermatological conditions in the home. It typically consists of an energy generator and an attached applicator to apply the energy to the skin. It is designed to be operated by the patient typically for self body hair removal, skin rejuvenation, vascular and pigmented lesion removal, wrinkle reduction, collagen renewal, acne clearance, and/or mild to moderate psoriasis care.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
745074558
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09361725000142BON CHARGECold & Heat Therapy Massage Gun2024-12-23
09361725000159BON CHARGEInfrared PEMF Sauna Dome2024-12-23
09361725000005BON CHARGEBullet Red Light Therapy Device2024-12-17
09361725000012BON CHARGEDemi Red Light Therapy Device2024-12-17
09361725000029BON CHARGEMax Red Light Therapy Device2024-12-17
09361725000036BON CHARGESuper Max Red Light Therapy Device2024-12-17
09361725000043BON CHARGERed Light Face Mask2024-12-17
09361725000050BON CHARGERed Light Neck and Chest Mask2024-12-17
09361725000074BON CHARGEMini Red Light Therapy Device2024-12-17
09361725000081BON CHARGERed Light Face Wand2024-12-17
09361725000098BON CHARGEPEMF Wrap2024-12-17
09361725000104BON CHARGEPEMF Mat Mini2024-12-17
09361725000111BON CHARGEPEMF Mat Demi2024-12-17
09361725000128BON CHARGEPEMF Mat Max2024-12-17
09361725000135BON CHARGESauna Blanket2024-12-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06979994630026CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630033CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630040CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
08800190200004OLIZLTBIO Co., Ltd.ILY2026-08-26
06977782490029QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILY2026-08-22
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08800020111852HILTHERAJeisys Medical Inc.ILY2026-07-21
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G710E320Velara Elite 32SUNSHINE USA, LLCILY2026-05-11
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