FDA.reportPublic FDA data

SMARTLUX MINI

Primary DI
08800077100045
Brand
SMARTLUX MINI
Company
Medmix Co., Ltd.
Model
D478000
Device description
SMARTLUX MINI is the combination of low power beam irradiator and infrared irradiator, and it is KGMP, CE/MDD class IIa class medical equipment. Your attention to prevent danger or injury is required. Please read User’s Manual carefully before you use medical equipment, and if you have any questions on safety, application, or operation of the equipment, please contact MEDMIX Co., Ltd. or its distributor.
Published
2022-07-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221083000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221083000Smartlux MiniMedmix Co., Ltd.2022-07-12GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800077100045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800077100045088000771000458800077100045

GMDN Terms#

Term, Definition table
TermDefinition
Red-light phototherapy unit, professionalAn electrically-powered device designed to emit red light for phototherapy primarily to accelerate healing of cutaneous/mucosal wounds, treat mild skin disorders (e.g., mild acne), intraoral or nasal conditions, and/or treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood circulation. It is a non-wearable device which may be in the form of a hand-held, freestanding or mounted unit, and is intended to be used by a healthcare professional in a clinical setting.

Regulatory Flags#

DUNS number
557812813
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975981280045RedfySunPlus LED Technology Co., Ltd.ILY2026-10-21
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06975981280144RedfySunPlus LED Technology Co., Ltd.ILY2026-10-21
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00840456400814MOSES RaydarLUMENIS LTD.GEX2026-10-13
00840456400821MOSES RaydarLUMENIS LTD.GEX2026-10-13
00840456401293MOSES RaydarLUMENIS LTD.GEX2026-10-13
00840456401309MOSES RaydarLUMENIS LTD.GEX2026-10-13
B17731226455L0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-10-08
B17700100852TSS0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-09-30
B17700100853TSS0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-09-30
00850012528630ILYEO bodyJoylux, Inc.ILY2026-09-29
00850061407221LS Pro SystemsWELLNESS WITHOUT LIMITS LLCILY2026-09-24
06970453310015MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06970453310084MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06970453310114MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06971679500105LED Therapy DeviceBeijing Nubway S&T Co., Ltd.GEX2026-09-24
06974958310594mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06974958310600mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06974958310617mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06974958310624mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06979994630002CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630019CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
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