FDA.reportPublic FDA data

NEWA Kit

Primary DI
07290014660458
Brand
NEWA Kit
Company
ENDYMED MEDICAL LTD
Model
1.5, Ivory demo
Catalog number
ND_PRD00200
Device description
The EndyMed Newa is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults woman who have Fitzpatrick skin types I-IV.
Published
2018-09-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PAYOver-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PAYOver-The-Counter Radiofrequency Coagulation Device For Wrinkle ReductionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN150005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN150005000Newa Skin Therapy SystemEndymed Medical, Ltd.2015-12-18PAY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290014660455PackageGS110Not in Commercial Distribution
07290014660458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001466045517290014660455
07290014660458072900146604587290014660458

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin/body contouring systemAn assembly of devices intended to use a combination of noninvasive energies and methods to locally reduce the subcutaneous fat layer, cellulite manifestation, and loose or wrinkled skin appearance. It consists of an electrically-powered control unit/generator to produce two or more energy modalities [e.g., radio-frequency, thermal/cryogenic (for cryolipolysis), high intensity focused ultrasound (HIFU), infrared light], and body-surface applicators to apply the treatment to the target area (e.g., chin, hips, abdomen, thighs); some types are additionally capable of applying vacuum.

Contacts#

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

Regulatory Flags#

DUNS number
531958689
Device count
1
Kit
true
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
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
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
07290016586794MyLiftPOLLOGEN LTDPAY2026-02-22
07290016586817AURAPOLLOGEN LTDPAY2026-02-22
07290016586671GENEO, GLO2FACIAL, ELITEPOLLOGEN LTDPAY2025-02-11
07640260120044FAQ 102Foreo ABPAY2024-07-18
07640260120051FAQ 103Foreo ABPAY2024-07-18
07640260120112FAQ 102Foreo ABPAY2024-07-18
07640260120037FAQ 101Foreo ABPAY2024-03-01
17290019840227Silk'nSilkn Beauty Ltd.PAY2024-01-30
17290019840234Silk'nSilkn Beauty Ltd.PAY2024-01-30
27290019840224Silk'nSILKN BEAUTY LTDPAY2024-01-30
27290019840231Silk'nSILKN BEAUTY LTDPAY2024-01-30
07290016586459Desire model UPOLLOGEN LTDPAY2023-12-15
07290016586626STOP VX2 MODEL U POLLOGEN LTDPAY2023-12-14
07290014660120NEWA+, Kit, US, PINKENDYMED MEDICAL LTDPAY2023-11-20
17290014660127NEWA+, Kit, US, PINKENDYMED MEDICAL LTDPAY2023-11-20
17290019840005Silk'nSilkn Beauty Ltd.PAY2023-09-14
17290019840036Silk'nSilkn Beauty Ltd.PAY2023-08-15
07290019840039Silk'nSILKN BEAUTY LTDPAY2023-08-15
07290014660113NEWA PLUS KitENDYMED MEDICAL LTDPAY2022-01-09
17290014660110NEWA PLUS KitENDYMED MEDICAL LTDPAY2022-01-09
07290016586466STOP VX GOLD MODEL UPOLLOGEN LTDPAY2021-11-07
07290014660083NEWA KitENDYMED MEDICAL LTDPAY2021-09-23
17290112452013Silk'n HOME SKINOVATIONS LTDPAY2021-08-08
17290112451559Silk'nHOME SKINOVATIONS LTDPAY2021-08-02
07290016586442STOP VX MODEL UPOLLOGEN LTDPAY2021-06-30
07290014660021NEWA PLUS KitENDYMED MEDICAL LTDPAY2021-04-28
17290014660028NEWA PLUS KitENDYMED MEDICAL LTDPAY2021-04-28
07290018007686STOP XPOLLOGEN LTDPAY2020-12-22
07290014660014NEWA PLUS KitENDYMED MEDICAL LTDPAY2019-11-24
07290018007303STOP XPOLLOGEN LTDPAY2019-11-07