INMODE M.D LTD

INMODE M.D LTD

Address:Tavor Building (POB 533),Yokneam Northern,IL

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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

Electrosurgical, Cutting & Coagulation & Accessories (GEI) (5) Powered Light Based Non-Laser Surgical Instrument With Thermal Effect (ONF) (3) Massager, Therapeutic, Electric (ISA) (1) Massager, Vacuum, Light Induced Heating (NUV) (1) Massager, Vacuum, Radio Frequency Induced Heat (PBX) (1) Powered Laser Surgical Instrument (GEX) (1)

Premarket Exempt

No

Clear

InMode RF™ - 07290016633016 Catalog Number : AG604881A

Device Description : InMode RF system

Device Class : 2

Duns Number: 600417351

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

FRACTORA - 07290016633023 Catalog Number : AG601398A

Device Description : Fractora system

Device Class : 2

Duns Number: 600417351

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

InMode - 07290016633047 Catalog Number : AS602099A

Device Description : InMode system

Device Class : 2

Duns Number: 600417351

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

FRACTORA - 07290016633054 Catalog Number : AG601261A

Device Description : Fractora

Device Class : 2

Duns Number: 600417351

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Forma - 07290016633061 Catalog Number : AG603799A

Device Description : Forma

Device Class : 2

Duns Number: 600417351

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

BodyFX - 07290016633085 Catalog Number : AS600874A

Device Description : BodyFX

Device Class : 1

Duns Number: 600417351

Premarket Exempt : No

Product Code : NUV, ISA

Prescription Use : Yes

Device Count : 1

Lumecca 515 - 07290016633108 Catalog Number : AS601863A

Device Description : Lumecca 515

Device Class : 2

Duns Number: 600417351

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

Lumecca 580 - 07290016633115 Catalog Number : AS601864A

Device Description : Lumecca 580

Device Class : 2

Duns Number: 600417351

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

Diolaze - 07290016633139 Catalog Number : AS602143A

Device Description : Diolaze

Device Class : 2

Duns Number: 600417351

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MiniFX - 07290016633238 Catalog Number : AG604696A

Device Description : MiniFX

Device Class : 2

Duns Number: 600417351

Premarket Exempt : No

Product Code : GEI, PBX

Prescription Use : Yes

Device Count : 1

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