FDA.reportPublic FDA data

EndyMed Pure iFine Handpiece

Primary DI
07290016814033
Brand
EndyMed Pure iFine Handpiece
Company
ENDYMED MEDICAL LTD
Model
iFine Handpiece
Catalog number
ND_PRD00075
Device description
The handpiece is used as an accessory to EndyMed Pure system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides.
Published
2018-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K120513000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120513000GLOW BY ENDYMEDEndymed Medical, Ltd.2012-05-08OUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016814033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016814033072900168140337290016814033

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin contouring systemAn assembly of devices that uses a combination of energies to temporarily minimize the manifestation of cellulite and loose or wrinkled skin. It typically consists of an applicator attached to an energy-producing generator and possibly other components. The applicator is applied to the body and may emit radio-frequency [typically in the bands of 1 megahertz (MHz)], infrared light, and/or other forms of energy, to heat skin/subdermal tissues for the production of a smooth-skin appearance. Vacuum may also be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-363-9633service@endymed.com

Regulatory Flags#

DUNS number
531958689
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016814675EndyMed Intensif 10 pack tips package Intensif 10 pack tips package (JOYMED)ND_PRD00177 2026-05-07
07290016814354EndyGel EndyGel 350 mlND_PRD000162023-07-04
07290016814569PRO MAX, System, 110VPro Max System 110V blackND_PRD00475-00 2025-11-17
07290016814408EndyMed PRO MAX, System, 110VPro Max System 110V white ND_PRD00464-002024-05-16
07290016814415endyMed PRO MAX, Intensif MAX HandpieceIntensif MAX HandpieceND_PRD00462-00 2024-05-16
07290016814422EndyMed PRO MAX, Small MAX HandpieceSmall MAX HandpieceND_PRD00470-002024-05-16
07290016814439EndyMed PRO MAX, FSR MAX Handpiece FSR MAX HandpieceND_PRD00471-002024-05-16
07290016814446EndyMed PRO MAX, iFine MAX Handpiece iFine MAX Handpiece ND_PRD00469-002024-05-16
07290016814453EndyMed PRO MAX,Shaper MAX HandpieceShaper MAX HandpieceND_PRD00466-002024-05-16
07290016814460EndyMed PRO MAX,Mini Shaper MAX HandpieceMini Shaper MAX Handpiece ND_PRD00468-002024-05-16
07290016814477EndyMed PRO MAX, Contour MAX HandpieceContour MAX HandpieceND_PRD00467-002024-05-16
07290014660458NEWA Kit1.5, Ivory demoND_PRD002002018-09-30
07290016814668PURE DentAPURE DentA 110VND_PRD00480-002024-11-06
07290016814019EndyMed Pure Small HandpieceSmall HandpieceND_PRD000742018-12-31
07290016814040EndyMed Pure Shaper HandpieceShaper HandpieceND_PRD000972018-12-31
07290016814057EndyMed Pure mini-shaper Handpiecemini-shaper HandpieceND_PRD001782018-12-31
07290016814071EndyMed PRO mini-shaper Handpiecemini-shaper HandpieceND_PRD00179 2018-12-31
07290016814088EndyMed PRO Contour HandpieceCountour HandpieceND_PRD00180 2018-12-31
07290016814101EndyMed Pro Small HandpiecePro Small HandpieceND_PRD000052018-12-31
07290016814132EndyMed Pro iFine HandpiecePro iFine HandpieceND_PRD00036 2018-12-31

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