Medmix Co., Ltd.

Address:214 Songdomirae-ro,Yeonsu-gu Incheon,KR

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Lamp, Infrared, Therapeutic Heating (ILY) (1) Powered Laser Surgical Instrument (GEX) (1)

Premarket Exempt

Yes

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Medmix - 08800077100045 Catalog Number :

Device Description : SMARTLUX MINI is the combination of low power beam irradiator and infrared irrad 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.

Device Class : 2

Duns Number: 557812813

Premarket Exempt : Yes

Product Code : GEX, ILY

Prescription Use : Yes

Device Count : 1

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