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
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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 unitAn 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 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
557812813
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

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