FDA.reportPublic FDA data

EndyMed Pure Intensif Handpiece

Primary DI
07290016814217
Brand
EndyMed Pure Intensif Handpiece
Company
ENDYMED MEDICAL LTD
Model
Intensif Handpiece
Catalog number
ND_PRD00235
Device description
The Intensif applicator is intended for use in dermatologic and general surgical procedure for electrocoagulation nd hemostasis
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
OUHSkin Resurfacing Rf Applicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
OUHSkin Resurfacing Rf ApplicatorGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130501000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130501000INTENSIFEndymed Medical, Ltd.2014-03-13OUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016814217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016814217072900168142177290016814217

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
1-855-363-9633support@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
07290016814033EndyMed Pure iFine HandpieceiFine HandpieceND_PRD000752018-12-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105004DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105059DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105066DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105073DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020106827DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020107626DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020107633DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110565INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110640FootswitchJeisys Medical Inc.GEI2026-07-16
B382SD08890310101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD08890320101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720520001Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720585030Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD84032220032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8406210032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89029200Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89039060Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89139290Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8917450Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89179290Surgical DirectSurgical Direct, Inc.GEI2026-07-14