FDA.reportPublic FDA data

Neogen

Primary DI
05060440520105
Brand
Neogen
Company
ENERGIST LIMITED
Model
Handpiece Blk
Catalog number
830-009
Device description
Neogen Handpiece Complete (Black)
Published
2021-05-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132754000
K221873000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132754000NEOGEN PSR SYSTEMEnergist, Ltd.2013-12-12GEI
K221873000NeoGen PSR SystemEnergist Limited2023-01-12GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060440520105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060440520105050604405201055060440520105

GMDN Terms#

Term, Definition table
TermDefinition
Nitrogen plasma skin surface treatment systemA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
735769528
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060440520198NeoGenNeoGen 5mm 1x Nozzle (Black)830-0062019-04-03
05060440520204NeoGenNeoGen 25mm 1x Nozzle (Black)830-0242019-04-03
05060440520235NeoGenNeoGen 5mm 3x Nozzle (Black)830-0572019-04-02
05060440520242NeoGenNeoGen 25mm 3x Nozzle (Black)830-0582019-04-02
05060440520099NeoGenPSR830-0082019-04-01
05060440520334NeoGen SPA Grey Trolley930-0232021-08-05
05060440520129Neogen Handpiece Gry830-0312021-05-13
05060440520273Neogen Trolley Blk930-0022021-05-13
05060440520280Neogen Trolley Gry930-0202021-05-13
05060440520211NeoGenNeoGen 5mm 1x Nozzle (Grey)830-0332019-04-03
05060440520228NeoGenNeoGen 25mm 1x Nozzle (Grey)830-0232019-04-03
05060440520259NeoGenNeoGen 5mm 3x Nozzle (Grey)830-0592019-04-03
05060440520266NeoGenNeoGen 25mm 3x Nozzle (Grey)830-0602019-04-03
15060440520195NeoGenNeoGen 5mm 1x Nozzle (Black)830-0062019-04-03
15060440520201NeoGenNeoGen 25mm 1x Nozzle (Black)830-0242019-04-03
15060440520218NeoGenNeoGen 5mm 1x Nozzle (Grey)830-0332019-04-03
15060440520225NeoGenNeoGen 25mm 1x Nozzle (Grey)830-0232019-04-03
15060440520256NeoGenNeoGen 5mm 3x Nozzle (Grey)830-0592019-04-03
15060440520263NeoGenNeoGen 25mm 3x Nozzle (Grey)830-0602019-04-03
15060440520232NeoGenNeoGen 5mm 3x Nozzle (Black)830-0572019-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840319759042Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759059Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759066Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764089VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764133VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764140VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764157VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
00198506091261ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-03
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCGEI2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCGEI2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCGEI2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCGEI2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCGEI2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCGEI2026-06-03
00846338006044Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006051Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006068Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006082Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006099Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006105Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006112Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006129Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006136Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02