FDA.reportPublic FDA data

EndyMed Intensif 10 pack tips package

Primary DI
07290016814330
Brand
EndyMed Intensif 10 pack tips package
Company
ENDYMED MEDICAL LTD
Model
Intensif 10 pack tips package
Catalog number
ND_PRD00177
Device description
Tips that are used with the intensif handpiece (3rd generation).
Published
2019-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
07290016814330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016814330072900168143307290016814330

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
Lot or batch
true
Expiration date on label
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
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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