ENERGIST LIMITED

Address:2 Park Pavilions, Clos Llyn Cwm,Swansea,GB

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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) (10)

Premarket Exempt

Clear

NeoGen - 05060440520099 Catalog Number : 830-008

Device Description : A mobile assembly of devices intended to treat a variety of skin conditions (e.g A mobile assembly of devices intended to treat a variety of skin conditions (e.g., acne scars, actinic keratosis, wrinkles, superficial skin lesions, warts) through controlled heating of the skin surface via application of nitrogen plasma. It consists of a mains electricity (AC-powered) generator/control unit and a hand-held applicator; it may include a N2 cylinder(s) and additional hardware (e.g., foot-switch). Typically radio-frequency energy is used to convert N2 into N2 plasma which exits the handpiece as a pulsed beam. This device is intended to be used by a professional in a clinical setting.

Device Class : 2

Duns Number: 735769528

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Neogen - 05060440520105 Catalog Number : 830-009

Device Description : Neogen Handpiece Complete (Black)

Device Class : 2

Duns Number: 735769528

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Neogen - 05060440520129 Catalog Number : 830-031

Device Description : Handpiece Complete (Grey)

Device Class : 2

Duns Number: 735769528

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

NeoGen - 05060440520198 Catalog Number : 830-006

Device Description : NeoGen 5mm 1x Nozzle (Black)

Device Class : 2

Duns Number: 735769528

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

NeoGen - 05060440520204 Catalog Number : 830-024

Device Description : NeoGen 25mm 1x Nozzle (Black)

Device Class : 2

Duns Number: 735769528

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

NeoGen - 05060440520211 Catalog Number : 830-033

Device Description : NeoGen 5mm 1x Nozzle (Grey)

Device Class : 2

Duns Number: 735769528

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

NeoGen - 05060440520228 Catalog Number : 830-023

Device Description : NeoGen 25mm 1x Nozzle (Grey)

Device Class : 2

Duns Number: 735769528

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

NeoGen - 05060440520235 Catalog Number : 830-057

Device Description : NeoGen 5mm 3x Nozzle (Black)

Device Class : 2

Duns Number: 735769528

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

NeoGen - 05060440520242 Catalog Number : 830-058

Device Description : NeoGen 25mm 3x Nozzle (Black)

Device Class : 2

Duns Number: 735769528

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

NeoGen - 05060440520259 Catalog Number : 830-059

Device Description : NeoGen 5mm 3x Nozzle (Grey)

Device Class : 2

Duns Number: 735769528

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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