FDA.reportPublic FDA data

endyMed PRO MAX, Intensif MAX Handpiece

Primary DI
07290016814415
Brand
endyMed PRO MAX, Intensif MAX Handpiece
Company
ENDYMED MEDICAL LTD
Model
Intensif MAX Handpiece
Catalog number
ND_PRD00462-00
Device description
The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic procedures. The Intensif MAX Handpiece is intended for use in dermatologic procedures for electrocoagulation and hemostasis.The Intensif MAX handpiece operates with an Intensif tip connected.
Published
2024-05-16
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
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
07290016814415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016814415072900168144157290016814415

GMDN Terms#

Term, Definition table
TermDefinition
Cosmetic micro-needling electronic handpiece, professionalA hand-held, electrically-powered device intended to be used in combination with a micro-needle cartridge (which contains micro-needles) to create high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as part of collagen induction therapy (CIT). It includes controls to allow for treatment adjustments (e.g., puncture depth, frequency); a disposable micro-needle cartridge may be included. It is intended for clinical use by a healthcare provider to treat stretch marks, acne scarring, hyperpigmentation, wrinkles, and/or hair loss; it is not intended for energy-based skin treatment. This is a reusable device.

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
Manufacturing 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
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
07290016814132EndyMed Pro iFine HandpiecePro iFine HandpieceND_PRD00036 2018-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776424527MillenniumAvalign Technologies, Inc.GEI2026-08-07
00841019123935KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-07
00841019123942KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-07
07613327548235NeptuneSTRYKER CORPORATIONGEI2026-08-07
08800017100920VIVACE Microneedle Cartridgeshenb Co., Ltd.GEI2026-08-07
00190776408718MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422677MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422820MillenniumAvalign Technologies, Inc.GEI2026-08-03
B382SD5657815600Surgical DirectSurgical Direct, Inc.GEI2026-08-03
00190776407445MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422332MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422516MillenniumAvalign Technologies, Inc.GEI2026-07-31
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
00198506093562ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
07613327688849MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688856MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688979MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688986MalisSTRYKER CORPORATIONGEI2026-07-29
08800020110688INTRAGen HandpieceJeisys Medical Inc.GEI2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP81Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP82Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP83Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP84Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP85Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP89Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
00190776407285MillenniumAvalign Technologies, Inc.GEI2026-07-28
00190776407292MillenniumAvalign Technologies, Inc.GEI2026-07-28
00198506092770ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092886ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28