GENESIS BIOSYSTEMS, INC.

Address:1500 Eagle Ct.,Lewisville,TX,75057,US

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Filters

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) (2) System, Suction, Lipoplasty (MUU) (2)

Premarket Exempt

No Yes

Clear

LipiVage® - 00818257020012 Catalog Number :

Device Description : LipiVage Harvester

Device Class : 2

Duns Number: 067933700

Premarket Exempt : Yes

Product Code : MUU

Prescription Use : No

Device Count : 1

LipiVage® - 00818257020029 Catalog Number :

Device Description : LipiVage Harvester with cannula

Device Class : 2

Duns Number: 067933700

Premarket Exempt : Yes

Product Code : MUU

Prescription Use : No

Device Count : 1

CoolBreeze - 00818257020074 Catalog Number :

Device Description : Cool Breeze LED Wand - Red

Device Class : 2

Duns Number: 067933700

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

CoolBreeze - 00818257020081 Catalog Number :

Device Description : Cool Breeze LED wand - Blue

Device Class : 2

Duns Number: 067933700

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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