LOTUS GLOBAL GROUP, INC, THE

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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

Powered Laser Surgical Instrument (GEX) (4) Lamp, Infrared, Therapeutic Heating (ILY) (2)

Premarket Exempt

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OMNILUX - B434EM1258S0 Catalog Number :

Device Description : OMNILUX MEDICAL BASE

Device Class : 2

Duns Number: 969797406

Premarket Exempt : No

Product Code : ILY, GEX

Prescription Use : Yes

Device Count : 1

OMNILUX - B434EM1310 Catalog Number :

Device Description : OMNILUX MEDICAL BLUE HEAD

Device Class : 2

Duns Number: 969797406

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

OMNILUX - B434EM1387 Catalog Number :

Device Description : OMNILUX MEDICAL PLUS HEAD

Device Class : 2

Duns Number: 969797406

Premarket Exempt : No

Product Code : ILY, GEX

Prescription Use : Yes

Device Count : 1

OMNILUX - B434EM1654 Catalog Number :

Device Description : OMNILUX MEDICAL REVIVE2 HEAD

Device Class : 2

Duns Number: 969797406

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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